Department: ENG / Location: [not specified]

Job Responsibilities

1. Responsible for maintenance and operation of black utilities and facilities;
2. Responsible for operation of process gas system, for example N2, O2, CO2, CDA, etc.
3. Responsible for maintenance and operation of HVAC system, including HVAC system for classified and non-classified area;
4. Responsible for maintenance and operation of electric power system, boiler and industrial steam system, chilled and hot water system, waste water treatment system, water pretreatment system, etc.
5. Other work arranged by superior leaders.

Job Requirements

1. Junior college degree or above in mechatronics, electrical automation or related engineering, with at least three years of professional experience;
2. Experienced in pharmaceutical plant maintenance are preferred, have a certain understanding of GMP documents and concept; relevant special equipment operation certificates, such as low-voltage electrician certificate, high-voltage electrician certificate, boiler operation certificate, pressure vessel operation certificate, etc.
3. Basic understanding of black and clean utilities, for example chiller, boiler, air compressor, HVAC, clean room;
4. Strong operational ability and resistance to pressure;
5. Adaptable to shift work.

Department: HR & Admin & GA & EHS / Location: Wuhan, China

Job Responsibilities

1. Assist management team with travelling and meeting arrangement
2. Sort and file project application materials and audit materials
3. Assist in activity planning and organization
4. Other work arranged by superior leaders.

Job Requirements

1. Bachelor or above, administrative or related major;
2. Good communication and teamwork skills;
3. Proficiency in office software;
4. Ability to work under pressure;
5. Good English listening, speaking, reading and writing skills.

Department: CSV&IT / Location: Wuhan, China

Job Responsibilities

1. Collaborating with various functions to identify the business needs for end user computing support and identify and implement solutions to meet the requirement;
2. Support Personal Computer (PC) setup and deployment for new employees using standard hardware and software. The hardware include Desktop, Laptop and Tablet etc. Peripherals include scanners etc. The software include Microsoft, Antivirus, Backup etc;
3. Support end users’ technical requests and implement the solutions to meet the requirement;
4. Perform security administration (e.g. Active Directory, Microsoft application, NAS Folders access);
5. Perform routine tasks of data backup for both servers and clients PCs and also data recovery (if need arises) and conduct disaster recovery testing;
6. Assists with technical equipment set-up/breakdown during company events/training sessions;
7. Procurement of End User Computing hardware and software, train users on software and equipment usage;
8. Maintain up to date IT hardware and software inventory;
9. Maintaining technical documentation related to IT system configurations, process and procedure;
10. Other work arranged by superior leaders.

Job Requirements

1. Bachelor degree or above, major in computer, 2 to 5 years Information Technology working experience as the end users support;
2. Hands-on working experience of installing, configuring, maintaining and troubleshooting computing hardware, peripherals and software;
3. Hands-on working experience of Active Directory administration, Windows Operating Systems, anti-virus, anti-spyware, imaging and disaster recovery etc;
4. Familiar with Microsoft Applications (MS Office, Visio, Project);
5. Good communication and teamwork skill can provide users with quality customer service;
6. Meticulous, prudent and patience in dealing with requests and problems.
7. Good communication skills in Chinese and English (reading, writing, speaking) , able to communicating smoothly with other departments.

Department: MML / Location: Wuhan, China

Job Responsibilities

1. Maintains receiving, warehousing, and distribution operations by initiating, coordinating, and enforcing program, operational, shipping, and personnel policies and procedures, safeguards warehouse operations and contents by establishing and monitoring security procedures and protocols;
2. Completes warehouse operational requirements and following up on work results;
3. Maintains physical condition of warehouse by planning and implementing new design layouts; inspecting equipment; issuing work orders for repair and requisitions for replacement;
4. Support warehouse storage requirements and ensure efficient space utilization. Initiate, coordinate and enforce optimal operational policies and procedures;
5. Support to introduce reports and statistics regularly (In/Out Status report, obsolete stock report, damaged inventory, etc.);
6. Support maintaining warehouse resources, shipping supplies and other consumables, including minor facility maintenance;
7. Maintains safe and healthy work environment by establishing, following and enforcing standards and procedures; complying with EH&S regulations;
8. Controls inventory levels by conducting physical counts; reconciling with data ERP system.
9. Complies with government, local warehousing, material handling, and shipping requirements by studying existing and new legislation; enforcing adherence to requirements; advising management on needed actions;
10. Other work arranged by superior leaders.

Job Requirements

1. Bachelor’s degree in supply chain, logistics, or related discipline, prior experience in pharma / biotech is preferred;
2. Minimum working experience in Logistics / Warehouse of 2 years, strong inventory management experience;
3. Familiar with local GxP guidelines, policies and regulations is a plus. Experienced in ERP system is a plus;
4. Forklift certification a plus;
5. Ability to communicate and collaborate across functional groups in completing necessary job requirements.

Department: MML / Location: Wuhan, China

Job Responsibilities

1. Summarized the BOM list from MFG or MSAT department from different project, provide a material supply plan for material ordering, receiving and tracking;
2. Prepare stock for all consumable for internal departments, and organize issuing record. By analyzing the data，namely on hand stock, monthly consumption, shelf life, etc. to recalculate safety stock quantity;
3. Periodically communicate with procurement about material ordering and receiving status;
4. Control and evaluate the dispensing of materials that request by internal department according to their provided monthly consumption or any extra request;
5. According to the requirements by client, coordinate with internal group to solve all material supply related issue, and eventually assure material supply for every single project;
6. Understand receiving, warehousing, and distribution operations;
7. Controls inventory levels by conducting physical counts; reconciling with data ERP system;
8. Understand physical condition of warehouse by planning and implementing new design layouts; inspecting equipment; issuing work orders for repair and requisitions for replacement;
9. Support warehouse storage requirements and ensure efficient space utilization;
10. Support maintaining warehouse resources, shipping supplies and other consumables, including minor facility maintenance;
11. Good communication and teamwork skill;
12. Other work arranged by superior leaders.

Job Requirements

1. College degree or above in supply chain, logistics, or related discipline, forklift certification a plus;
2. Strong inventory management experience, Minimum working experience in Logistics, Warehouse management or planning work of 2 years;
3. Familiar with local GMP guidelines, policies and regulations and ERP system, working experience in pharma / biotech is preferred;
4. Ability to communicate and collaborate across functional groups in completing necessary job requirements;
5. Both basic oral and written communication skills in English and computer operation.

Department: Procurement / Location: Wuhan, China

Job Responsibilities

1. Be familiar with production plan and capacity, in charge of order placing, manage suppliers to ensure all raw materials on-time delivery with high quality, reasonable price.
2. Continuously drive cost savings, especially for the major suppliers annual discounts price negotiation.
3. Strict follow procurement work instruction, ensure all orders and price are completely compliance
4. Timely processing daily PR, invoices and other work.
5. Other work arranged by superior leaders.

Job Requirements

1. Bachelor’s degree or above, with background/experience in pharmacy, Biotech is preferred;
2. At least 1-3 years of buyer or related work experience;
3. Fluently at English writing and speaking;
4. Good skilled in Word, Excel, Viso, PPT and other office software, as well as data processing;
5. Good English listening, speaking, reading and writing skills.

Department: QA / Location: Wuhan, China

Job Responsibilities

1. Participate in the daily activities of the QA Department as assigned;
2. Work as directed to establish and maintain Quality Systems to ensure the manufacture, testing and distribution processes comply with applicable regulatory requirements;
3. Participate in the execution of the Product Complaint System and assist with product return, withdrawal or recall activities, as needed;
4. Maintain compliance of the Environmental Monitoring and Validation programs, participate in the internal auditing program for company, as required;
5. Create and revise Quality Assurance related documents in support of GMP; Provide QA input on GMP Facility and GMP Utilities issues such as qualification/ requalification, changes, maintenance, startups/ shutdown, disaster recovery, etc.
6. Review and approval of data for determining the disposition of GMP material (raw material, in­ process, drug substance, finished product, packaging, labeling and manufacturing components) and the review and approval of documents and data associated with the Stability Program;
7. Assist QA Document Control in managing the CAPA, Discrepancy and Change Control systems;
8. Assist in hosting regulatory, customer or due diligence inspections. Work closely with all departments, as assigned, to ensure timely responses and follow up of any observations;
9. Identify training needs and organize training interventions to meet quality standards;
10. Other work arranged by superior leaders;

Job Requirements

1. BS degree, scientific discipline preferred;
2. 2-5 years’ experience in a Quality regulated industry, pharmaceutical or medical device experience is preferred. Experience in the biosimilar quality environment is a plus;
3. In-depth knowledge of GMPs and related guidelines and regulatory requirements;
4. Proficiency in the use of Microsoft Office Applications;
5. Must be self-motivated with ability to independently handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines;
6. Good oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating effectively with other functions and management processes within Quality Assurance and multi-disciplinary teams.

Department: HR & Admin & GA & EHS / Location: Wuhan, China

Job Responsibilities

1. According to the annual recruitment needs, regularly search for suitable candidates, responsible for resume selection, personnel interview, follow-up interview results,etc.,recruitment channels include, but not limited to, internet, campus, headhunting, job fairs;
2. Assist in the development of training plans, arrangements and implementation, including but not limited to new employee training, general skills training, and professional training;
3. Assist personnel in daily work, including procedures for employee entry, departure, promotion, transfer, etc.; establishment, maintenance and storage of employee files.
4. Responsible for handing social security and provident fund related matters;
5. Assist in the construction of corporate culture and the maintenance of employee relationships, including but not limited to the planning and arrangement of employee activities;
6. Attendance management, overtime management, working hours management, file management, etc.
7. Other work arranged by superior leaders.

Job Requirements

1. Bachelor degree or above, human resources management, business management, business management and other related majors, accepting fresh graduates;
2. Good communication and learning skills;
3. Careful and serious work, proactive, principled and stress-resistant;
4. Skilled in using office software;
5. Good English listening, speaking, reading and writing skills.

Department: RA / Location: Wuhan, China

Job Responsibilities

1. Develop the operation procedures for various project documentations form receiving, numbering, storage, transfer, archive etc.
2. Capable to develop the documentation matrix for access control on the server;
3. Management of the Project folder access and control;
4. Daily operation of the documentation receiving, numbering storage, transfer, archive with Engineering consultant, local design institute, equipment vendors and service contractors etc;
5. Prepare, collect and handover all of the documentation to the end users at end of the project;
6. Others tasks assigned by the project;

Job Requirements

1. Bachelor degree or higher in a scientific discipline
2. At least 3 year’s experience as documentation controller or engineer in international engineering project background;
3. Proficiency in the use of Microsoft Office Applications;
4. Good oral and written communication skills in Chinese and English (Read, Write, Verbal).

Department: Quality Control/ Location: Wuhan, China

Job Responsibilities

1. Understand technical aspects of the job, best practices, and adhere to cGMP compliance.
2. Management of culture medium and strains.
3. Draft and execute the method validation protocol for Bioburden, Endotoxin, and Sterility test according to ChP, USP and EP.
4. Communication with client about the gaps and questions of method validation for Bioburden, Endotoxin, and Sterility analysis, and resolve the problems, if any.
5. Handle the deviation and micro data deviation event.
6. Training members of the department and other departments as necessary.
7. Develop and implement all necessary SOP/test procedures.
8. Any other tasks as assigned by the supervisor.

Job Requirements

1. Bachelor’s degree in Biology or related discipline.
2. At least 3 years working experience in the Microbiological laboratory of pharmaceutical company.
3. Good communication skill and the management experience is better.
4. Thorough knowledge of GMP regulations and documentation.
5. Have the ability to written write technical documents by English, and it’s better to have the ability to communicate in English.

Department: PSG / Location: Wuhan, China

Job Responsibilities

1. According to the requirements of the project and experiment, in-depth understanding of the technical background and technical characteristics of the project, the development of alternative, continuous and repeatable biological activity screening evaluation methods;
2. Independent completion of protein binding measurement and evaluation experiments for antibody drug analysis, including but not limited to various biomolecule target binding ability experiments;
3. Participate in the development and of protein-protein interaction measurements and method optimization.
4. Participate in the preliminary research and development of biopharmaceutical evaluation, biological stability analysis of product stability research, participate in the writing of stability research reports.
5. Communicate effectively with the company’s internal and external departments to successfully complete the project on time;
6. Other work arranged by superior leaders.

Job Requirements

1. Master degree or above, major in life science, chemistry, biochemistry, molecular biology, with 2-3 years of theoretical and practical foundation in protein science, structural biology and biochemistry;
2. Practical experience in instrument analysis, familiar with protein interaction analysis, familiar with various analysis techniques, such as Biacore (SPR), ForteBio Octet (BLI), and ITC. And experience in protein structural biology and biophysics is preferred;
3. Excellent oral and written communication skills in English.

Department: Quality Control/ Location: Wuhan, China

Job Responsibilities

1. Lead, develop and maintain a robust and stable microbiology and environmental monitoring team, with high productivity.
2. Responsible for GMP compliance of the team. Ensure all the testing are completed in a timely manner according to relevant SOP and GMP standard.
3. Manage microbial testing activities in raw materials, intermediate, DS and DP.
4. Design and oversee microbiological validations as needed for various samples
5. Develop and implement Standard Operating Procedures for new processes and methods.
6. Implement and manage the EM programs for controlled areas.
7. Contribution to validation, qualification/requalification of the clean utilities/facilities
8. Act as Site Subject Matter Expert for Microbiology and Aseptic Control
9. Closely monitor the environmental monitoring contamination control status, proactively identify and solve any problem or risk.
10. Lead all the OOS investigation, deviation investigation, close CAPA, change control in a timely manner.
11. Host internal or outside audit.
12. Continuously improve lab operation compliance, efficiency, reduce cost.
13. Any other tasks as assigned by the director.

Job Requirements

1. Bachelor degree in chemistry, biology, microbiology or pharmaceutics discipline with 10+ years’ experience in pharmaceutical company quality control department, or Master’s degree with 8+ years’ experience.
2. Expertise with USP, EP, ChP requirement on environmental monitoring.
3. Well versed in microbiology based testing, with abundant hands-on experience.
4. Aseptic and sterile manufacturing experience strongly preferred.
5. Thorough knowledge of NMPA, EMA and US FDA GMP practices and regulations.
6. Communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups
7. Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.
8. Excellent oral and written communication skills in English.

Department: Expansion Project/ Location: Wuhan, China

Job Responsibilities

1. Responsible for cost estimation from earlier stage of the project till board approval;
2. Update the project budget regularly;
3. Develop and update of the project cash flow regularly;
4. Set up the SAP system with procurement, IT and Finance dept;
5. Lead the Change management of the project;
6. Claim settlement with vendors and contractors;
7. Responsible for the Project budget management;
8. Prepare the budget report regularly to SC;
9. Develop of WBS code with allocation of the budget for each WBS code;
10. Involved in the approval loop for all of the PR and Payment;
11. Support of the Capex project capitalization;
12. Others tasks assigned by the project.

Job Requirements

1. Bachelor education background;
2. At least 8 years’ experience as Project controller in Engineering field with international project background

Department: CSV&IT / Location: Wuhan, China

Job Responsibilities

1. Collaborating with various functions to identify the business needs and identify and implement solutions to meet the requirement.
2. Leading cross-functional teams to identify continuous improvements and implement them.
3. Leading the IT systems projects and ensuring that they meet the business requirements, cost and schedule. Systems include Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Chromatography Data System (CDS), Computerized Maintenance Management System (CMMS), Sensors Monitoring System (CMS), Enterprise Quality Management System (EQMS) etc.
4. Sourcing, selecting and managing the vendors to provide the technical solutions and consultancy implementation support.
5. Identifying and implementing industry ‘Best Practices’ for the IT solutions, processes and controls.
6. Supporting and maintaining the existing business systems inclusive of changes and upgrades.
7. Delivering documentation for the IT projects and also operational SOPs.
8. Conducting training for the computer systems.
9. Representing as the IT Application Subject Matter Expert during the regulatory and financial audits.

Job Requirements

1. 2 to 5 years’ IT working experience in a manufacturing environment. Working experience in the pharmaceutical or medical device industry is an added advantage.
2. Bachelor’s Degree in Computer Science, Engineering, Pharmaceutical Sciences, or a related scientific discipline required.
3. The ability to effectively prioritize and manage multiple project workloads.
4. Good communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions.
5. Good interpersonal and teamwork skills

Department: CSV&IT / Location: Wuhan, China

Job Responsibilities

1. Collaborating with various functions to identify the business needs for end user computing support and identify and implement solutions to meet the requirement.
2. Support Personal Computer (PC) setup and deployment for new employees using standard hardware and software. The hardware include Desktop, Laptop and Tablet etc. Peripherals include scanners etc. The software include Microsoft, Antivirus, Backup etc.
3. Support end users’ technical requests and implement the solutions to meet the requirement.
4. Perform security administration (e.g. Active Directory, Microsoft application, NAS Folders access).
5. Perform routine tasks of data backup for both servers and clients PCs and also data recovery (if need arises) and conduct disaster recovery testing.
6. Assists with technical equipment set-up/breakdown during company events/training sessions.
7. Train users on software and equipment usage.
8. Procurement of End User Computing hardware and software.
9. Maintain up to date IT hardware and software inventory.
10. Maintaining technical documentation related to IT system configurations, process and procedure.
11. Other tasks assigned by the company.

Job Requirements

1. 2 to 5 years Information Technology working experience as the end users support.
2. Hands-on working experience of installing, configuring, maintaining and troubleshooting computing hardware, peripherals and software.
3. Hands-on working experience of Active Directory administration, Windows Operating Systems, anti-virus, anti-spyware, imaging and disaster recovery etc.
4. Familiar with Microsoft Applications (MS Office, Visio, Project).
5. Reasonable communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions.
6. Good interpersonal and teamwork soft skill (e.g. Customer oriented) to provide good customer service to the end users and able to work as the team.
7. Meticulous, prudent and patience in dealing with requests and problems.

Department: HR&Admin&GA&EHS/ Location: Wuhan, China

Job Responsibilities

1. Familiar with the application status of government departments, understand the declaration process of government affairs, and follow the notice requirements, report the project on time according to the specific conditions of the enterprise, and independently complete the writing of government declaration documents;
2. Responsible for project contact, application, follow-up, acceptance, etc.;
3. Establish and maintain long-term stable cooperative relations with government departments;
4. The reception of government departments and important customers tour;
5. Complete other affairs arranged by the leader.

Job Requirements

1. Bachelor degree or above, biomedical related major is preferred;
2. More than one year of relevant work experience, familiar with project declaration policies and procedures, and have successful experience in project declaration of government funds;
3. Excellent editing skills;
4. Responsive, modest and rigorous attitudes towards work, excellent learning and logical abilities.
5. Strong internal and external coordination and communication skills, and strong resistance to stress.

Department: Business Development/ Location: Wuhan, China

Job Responsibilities

1. Responsible for business cooperation expansion, in-depth exploration of partner needs, finding new cooperation points, and promoting and promoting cooperation;
2. Maintain a good cooperative relationship between the company and customers, lead follow-up, including handling related matters during cooperation;
3. Follow and collect industry information and assist in planning and organizing related market activities;
4. Find potential customers and maintain long-term contacts; organize and entertain customers;
5. Other work arranged by superior leaders.

Job Requirements

1. Bachelor degree or above in biomedicine, pharmacy, medicine, chemistry, medical English or marketing;
2. Experience in the pharmaceutical industry is preferred;
3. Have excellent business language skills, telephone communication skills, interpersonal communication skills;
4. Good writing skills, can write related manuscripts and contracts;
5. Have good internal and external coordination and communication skills, can work effectively with the team; responsible, positive and optimistic;
6. Accept frequent business trips;

Department: DP Manufacturing/ Location: Wuhan, China

Job Responsibilities

1. Participate the daily activities of the Drug Product Manufacturing Group.
2. Author documents for drug product manufacturing processes.
3. Participate in the internal auditing program as required.
4. Provide input to QA on GMP facility issues and maintain oversight of the Environmental Monitoring and Validation programs.
5. Anticipate potential problems and take preventative actions and escalate process issues as necessary to ensure resolution.
6. Review documentation and check all calculations (eg batch records, labels equipment readings).
7. Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements.
8. Escalate process issues as necessary to ensure resolution.
9. Ensure GMP training requirements are complete and current.
10. Ensure all work is performed in a safe manner and meets the specifications for each service request.
11. Apply proper PPE (Personal Protective Equipment) to all work in the facility.
12. Clean and maintain the GMP facility and production equipment.

Job Requirements

1. College degree and above with 3 years’experience in the biotech industry; the degree should be in a biological or engineering discipline (Biotechnology, Biochemistry, Chemical/Biochemical Engineering, or equivalent).
2. Technical understanding with aseptic manufacturing process and working knowledge of GMP manufacturing and regulatory principles and requirements.
3. Experienced in aseptic drug product manufacturing, preferably protein drug.
4. Good oral and written communication skills in English and Mandarin (Read, Write, Verbal).
5. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
6. Communicate effectively and work professionally in a team environment.
7. Skilled in the use of computers and automation-drive equipment.
8. Must be flexible to work on any shift (day, night, weekend) and able to work prolong duration on your feet.

Department: Business Development / Location: Wuhan, China

Job Responsibilities

1. Develop and oversee strategic and tactical marketing campaigns in China, US, Europe and Asia.
2. Promote customer awareness of CBL CDMO business unit’s technologies; for new and existing customers.
3. Utilize the latest market and business intelligence tools to gain clear picture of the market and identify target markets for segmentation.
4. Execute targeting campaigns to support directed lead generation for identified capabilities or company profiles.
5. Collaborate with BD on key marketing strategy decisions and develop and deliver marketing materials.
6. Lead in CBL digital marketing strategies and online presence.
7. Maintain marketing budget and accountability for specific projects being managed with outside vendors.
8. Implement and monitor KPIs to evaluate effectiveness of marketing initiatives.
9. Maintain a strong understanding of the biotech industry and CDMO services around the world.
10. Maintain a working knowledge of overall company capabilities to drive collaboration across and within business units.

Job Requirements

1. BS/BA, bachelor degree (or above)
2. 5+ years related marketing experience in the biotech/pharmaceutical industry.
3. Marketing (international and domestic) experience is required.
4. Industry sales experience beneficial, but not required.
5. Distinct knowledge of the biotech industry, drug development, and the contract services business model though technical roles in development and / or manufacturing, etc.
6. Experience in the Pharma & Biotech / CDMO industry with customer facing or customer management experiences, preferably in a sales & business development or project management role is a plus.
7. Demonstrated strategic and tactical marketing, organizational, problem solving, and project management skills.
8. Solid business skills and a good understanding of the US/China biotech market.
9. Strong oral and written presentation skills (Chinese and English).
10. Expert knowledge of Microsoft Office applications, marketing related graphics software.
11. Ability to work effectively with cross-functional teams.
12. Ability to interact effectively with technical staff within CBL organization.
13. Ability to train, coach and mentor.
14. Ability to manage stressful situations and quickly changing priorities.
15. Detail orientation
16. 10% travel domestic /international

Department: Quality Control / Location: Wuhan, China

Job Responsibilities

1. Perform physical-chemical analysis of in-process sample, drug substance, drug product and stability sample according to SOPs.
2. Participate in method transfer, verification and method validation activities which include protocol drafting, execution, data analysis and completing the summary report.
3. Create and implement all necessary SOPs.
4. Satisfy cGMP compliance and handle quality event such as OOS, Deviation, CAPA and Investigation, independently.
5. Provide daily operation support in QC laboratory, such as equipment maintenance, 5S management.
6. Understand technical aspects of the job, best practices, and adhere to cGMP compliance.
7. Other work arranged by superior leaders.

Job Requirements

1. Master in a related scientific discipline (Chemistry, analytical-chemistry, biology or equivalent scientific experience if all other criteria are met) with 3+ years’ experience or Bachelor in a related scientific discipline, with 5+ years’ experience.
2. Extensive experiences in analytical testing for protein and antibody analysis, such as HPLC, CE, MS, iCE3, UV, etc;
3. Extensive experience in method development, qualification, validation and method transfer of physical-chemical methods;
4. In-depth knowledge of scientific, analytical, manufacturing and regulatory such as principles;
5. Work in GMP environment, and experienced in GMP documentation, testing and investigations;
6. Good English listening, speaking, reading and writing skills.
7. Team building experience is appreciated.

Department: Protein Science Group / Location: Wuhan, China

Job Responsibilities

1. Direct cell-based assay development activities and work closely with quality control (QC) team for analytical method transfer, qualification, and validation;
2. Lead analysis team members to conduct bioassays, including ELISA binding and cell-based assays;
3. Perform routine analysis of MSAT as well as GMP samples, including in-process according to SOPs;
4. Participate in the method development and validation of protein drug analytical method; implement the preparation of SOP and method validation reports;
5. Responsible for managing technical documents including operating procedures, drafts, reports, risk assessments, laboratory investigations, etc.;
6. Present to cross functional teams and effectively communicate critical analytical issues and solutions;
7. Communicate effectively with the company’s internal and external departments to successfully complete the project on time;
8. Other work arranged by superior leaders.

Job Requirements

1. Master degree or above, major in cell biology and molecular biology, PhD with 5 years or more and MS with 8 years or more of biochemical bioassay work experience, and experience in completing projects independently; have QC experience is a plus;
2. Have practical operation experience in instrument analysis, familiar with various analysis techniques (e.g. potency assay, ADCC, CDC, neutralization assay, FACS, ELISA and ECL), and master various biochemical test methods, confirmation, verification and transfer processes;
3. Understand ICH, USP, ChP regulations and guidelines;
4. Excellent oral and written communication skills in English.

Department: Protein Science Group / Location: Wuhan, China

Job Responsibilities

1. Responsible for process improvement of project products, including but not limited to process recipes, analytical performance evaluation, stability studies, etc,;
2. Lead analysis team members to conduct biochemical analysis, including Residual HCP, hcDNA, ProteinA testing, etc.;
3. Perform routine analysis of MSAT as well as GMP samples, including in-process according to SOPs.
4. Participate in the method development and validation of protein drug analytical method; implement the preparation of SOP and method validation reports
5. Responsible for managing technical documents including operating procedures, drafts, reports, risk assessments, laboratory investigations, etc.;
6. Review IND, BLA and other regulatory documents.
7. Communicate effectively with the company’s internal and external departments to successfully complete the project on time;
8. Other work arranged by superior leaders.

Job Requirements

1. Master degree or above, major in cell biology and molecular biology, with 6 years or more of biochemical analysis work experience, and experience in completing projects independently; have QC experience is a plus
2. Have practical operation experience in instrument analysis, familiar with various analysis techniques, familiar with upstream and downstream work processes, and master various biochemical test methods, confirmation, verification and transfer processes;
3. Understand ICH, USP, ChP regulations and guidelines.
4. Excellent oral and written communication skills in English.

Department: Sales & Marketing/Location: Wuhan, China

Job Responsibilities

1. Develop and oversee strategic and tactical marketing campaigns in China, US, Europe and Asia.
2. Promote customer awareness of CBL CDMO business unit’s technologies; for new and existing customers.
3. Execute targeting campaigns to support directed lead generation for identified capabilities or company profiles.
4. Collaborate with BD on key marketing strategy decisions and develop and deliver marketing materials.
5. Lead in CBL digital marketing strategies and online presence.
6. Maintain marketing budget and accountability for specific projects being managed with outside vendors.
7. Implement and monitor KPIs to evaluate effectiveness of marketing initiatives.
8. Maintain a strong understanding of the biotech industry and CDMO services around the world.
9. Maintain a working knowledge of overall company capabilities to drive collaboration across and within business units.

Job Requirements

1. BS/BA, bachelor degree (or above).
2. 5+ years related marketing experience in the biotech/pharmaceutical industry.
3. Marketing (international and domestic) experience is required.
4. Industry sales experience beneficial, but not required.
5. Distinct knowledge of the biotech industry, drug development, and the contract services business model though technical roles in development and / or manufacturing, etc.
6. Experience in the Pharma & Biotech / CDMO industry with customer facing or customer management experiences, preferably in a sales & business development or project management role is a plus.
7. Demonstrated strategic and tactical marketing, organizational, problem solving, and project management skills.
8. Strong oral and written presentation skills (Chinese and English).
9. Solid business skills and a good understanding of the US/China biotech market.
10. Ability to work effectively with cross-functional teams.
11. Ability to interact effectively with technical staff within CBL organization.
12. Ability to train, coach and mentor.
13. Ability to manage stressful situations and quickly changing priorities.
14. Detail orientation.

Department: Validation/Location: Wuhan, China

Job Responsibilities

1. Promote the safe operation of the company’s biotechnology facilities through personal initiative and compliance with company procedures.
2. Keep the verification status of the system directly affected in accordance with GMP. Review the factory acceptance and site acceptance test (FAT and SAT) documents prepared by the supplier.
3. Keep the verification status of the system directly affected in accordance with GMP. Review the factory acceptance and site acceptance test (FAT and SAT) documents prepared by the supplier.
4. Coordinate the development of process, cleaning and computerized system validation plans in collaboration with subject matter experts.
5. Implement validation and validation protocols in accordance with good document management practices and approved procedures. Prepare validation report.
6. Select and purchase equipment and consumables required to perform validation activities.
7. Develop standard operating procedures and related records covering the validation life cycle: risk assessment, urs, validation protocol, reports.
8. Develop standard procedures for the operation of test equipment used in validation testing, such as Kaye 2000 validation system.
9. Propose and close the deviation in time.
10. Identify verification requirements for proposed changes and corrective actions.
11. Comply with and continuously improve the company’s quality management system.
12. Draft system and component criticality assessment.
13. Lead validation risk assessment and document failure modes and mechanisms for controlling key quality attributes.
14. Review specifications for compliance with company quality and performance standards.

Job Requirements

1. Bachelor degree (preferably mechanical or chemical) plus at least 2 years of validation experience in pharmaceutical or medical device industry.
2. Experience in operation of pharmaceutical facilities, experience in establishment of plant facilities is preferred.
3. Good knowledge of engineering management practices, including documentation and operation of pharmaceutical facilities. Good understanding of GMP.
4. Familiar with good automated manufacturing practices (GAMP).
5. Good knowledge of pharmaceutical utility systems (such as PW, WFI, pure steam, compressed air and clean room HVAC), computerized systems, process equipment and analytical testing equipment.
6. Advanced document writing skills using Microsoft Office suite. Attention to detail, like to work in a highly structured way.
7. Strong communication skills in Chinese and English, able to communicate with the whole company and service providers, including understanding English technical documents.

Department: PSG/Location: Wuhan, China

Job Responsibilities

1. Independent completion of biological activity screening and evaluation experiments for antibody drug analysis, including but not limited to various biomolecule target binding ability experiments, and biological activity experiments based on specific cell biological mechanisms.
2. Participate in the bioassay development, including ADCC, CDC, ELISA binding and cell-based assays.
3. Perform routine analysis of samples of process development from MSAT and other non-GMP samples, including in-process samples.
4. Participate in the method development and validation of protein drug analytical method; implement the preparation of SOP and method validation reports.
5. Responsible for managing technical documents including operating procedures, drafts, reports, risk assessments, laboratory investigations, etc.
6. Present to cross functional teams and effectively communicate critical analytical issues and solutions.
7. Communicate effectively with the company’s internal and external departments to successfully complete the project on time.
8. Other work arranged by superior leaders.

Job Requirements

1. Master or PhD degree, major in cell biology, molecular biology or life sciences. With 2 years or more of experience in ligand binding and cell-based assay development. Perform bioassays independently. With R&D experience is a plus.
2. Have practical operation experience in instrument analysis, familiar with various analysis techniques (e.g. cell-based potency assay, ELISA binding, MSD, BLI, neutralization assay, FACS, ADCC and CDC), and master various biochemical test methods, confirmation, verification and transfer processes.
3. Understand ICH, USP, ChP regulations and guidelines.
4. Excellent oral and written communication skills in English.

Department: PSG/Location: Wuhan, China

Job Responsibilities

1. According to the requirements of the project and experiment, in-depth understanding of the technical background and technical characteristics of the project, the development of alternative, continuous and repeatable biological activity screening evaluation methods.
2. Participate in the development and of protein-protein interaction measurement, impurity determination and method optimization. Independent completion of protein binding measurement and evaluation experiments for antibody drug analysis, including but not limited to various biomolecule target binding ability experiments.
3. Lead analytical method development, qualification and method transfer and draft report.
4. Per SOPs, perform routine analysis of samples of process development and process optimization from MSAT and other non-GMP and GMP samples, including in-process samples.
5. Participate in the preliminary research and development of biopharmaceutical evaluation, biological stability analysis of product stability research, participate in the writing of stability research reports.
6. Perform analytical data analysis, data review and trending analysis.
7. Communicate effectively with the company’s internal and external departments to successfully complete the project on time.
8. Other work arranged by superior leaders.

Job Requirements

1. PhD degree, major in life science, chemistry, biochemistry, molecular biology, with theoretical and practical foundation in protein science, structural biology and biochemistry. With R&D experience is a plus.
2. Have experiences on HCP, residual DNA, residual Protein A, endotoxin and copy number measurement. Be familiar with equipment for biochemical analysis, such as SDS-PAGE, ELISA, qPCR and etc.
3. Practical experience in instrument analysis, familiar with protein interaction analysis, familiar with various analysis techniques, such as Biacore (SPR), ForteBio Octet (BLI), and Meso Scale Discovery (MSD).
4. Excellent oral and written communication skills in English.

Department: PSG/Location: Wuhan, China

Job Responsibilities

1. Responsible for the buildup and management of R & D quality system; participate in the establishment of R & D document system construction and maintenance; Review the implementation of R&D system documents, and form records and reports.
2. Participate in the investigation of R & D tests and laboratory abnormalities.
3. Responsible for the audit and management of original records of R & D; the standardization, completeness and authenticity of the research and development experiment logbook shall be randomly checked, and records shall be formed. Research and development assistant record should be spot check timeliness, authenticity, integrity.
4. Be responsible for the review of R&D draft process procedure, batch production record, quality standard, validation protocol/report, test operation procedure, test record/registration application, etc.
5. Be responsible for the review of R&D draft process procedure, batch production record, quality standard, validation protocol/report, test operation procedure, test record/registration application.
6. Develop training plan, responsible for quality management education and training, update and maintain training matrix other quality requirements. Perform other work supervisor arrangements and training record of R&D department.
7. Organize and carry out R&D quality system review regularly and be responsible for continuous improvement of quality system.
8. Responsible for daily quality management of R&D site, supervise and rectify the R&D site, including site record, equipment management, daily maintenance, personnel operation, etc.
9. Responsible for the quality management of the development process, including data, management, document management, record management and equipment management, deviation management, change control, risk control and evaluation.

Job Requirements

1. BS degree, scientific discipline preferred.
2. 1-5years experience in a quality regulated industry, pharmaceutical or medical device experience is preferred. Experience in the biologics is preferred.
3. Familiar with submission and registration.
4. Must be self-motivated with ability to independently handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
5. In-depth knowledge of GxPs and related guidelines and regulatory requirements.

Department: EHS/Location: Wuhan, China

Job Responsibilities

1. Responsible for the collection of fire-related laws, regulations and standards, identify and organize the implementation of relevant requirements to ensure compliance.
2. Responsible for the daily operation and maintenance of the company’s fire facilities, check the fire safety risks.
3. To be responsible for the fire technical support and scheme audit of the company’s new, reconstruction and expansion projects.
4. Responsible for the management of fire control room and keep communication with fire supervision departments at all levels.
5. Responsible for the formulation of fire emergency drill plan, the organization and management of fire emergency and the organization and implementation of fire drill.
6. Responsible for the management of fire maintenance providers and annual inspection of fire facilities.
7. Other tasks assigned by the leader.

Job Requirements

1. Bachelor degree or above, major in mechatronics, water supply and drainage, electrical, HVAC, fire protection is preferred.
2. At least 5 years working experience in fire protection maintenance and management.
3. Familiar with the functions, principles and material properties of various components of the fire protection system, due to the ability of analysis, management, communication and coordination.
4. Familiar with national and local fire protection laws, regulations and common rules and regulations, familiar with fire control related business work flow.
5. Hold fire protection qualification certificate.

Department: PD/Location: Wuhan, China

Job Responsibilities

1. Participate the daily activities of the Drug Product Manufacturing Group.
2. Author documents for drug product manufacturing processes.
3. Participate in the internal auditing program as required.
4. Provide input to QA on GMP facility issues and maintain oversight of the Environmental Monitoring and Validation programs.
5. Anticipate potential problems and take preventative actions and escalate process issues as necessary to ensure resolution.
6. Review documentation and check all calculations (eg batch records, labels equipment readings).
7. Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements.
8. Escalate process issues as necessary to ensure resolution.
9. Ensure GMP training requirements are complete and current.
10. Ensure all work is performed in a safe manner and meets the specifications for each service request.
11. Apply proper PPE (Personal Protective Equipment) to all work in the facility.
12. Clean and maintain the GMP facility and production equipment.

Job Requirements

1. S. degree with 3 years’ experience in the biotech industry; the degree should be in a biological or engineering discipline (Biotechnology, Biochemistry, Chemical/Biochemical Engineering, or equivalent).
2. Technical understanding with aseptic manufacturing process and working knowledge of GMP manufacturing and regulatory principles and requirements.
3. Experienced in aseptic drug product manufacturing, preferably protein drug.
4. Good oral and written communication skills in English and Mandarin (Read, Write, Verbal).
5. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
6. Communicate effectively and work professionally in a team environment.
7. Skilled in the use of computers and automation-drive equipment.

Department: EHS/Location: Wuhan, China

Job Responsibilities

1. According to the requirements of laws, regulations and relevant technical standards, establish the company’s environmental, occupational health, safety and fire control management system and make sure its effective implementation.
2. Conduct and carry out safety inspection, develop EHS check list, follow up and supervise to rectify，in order to eliminate potential safety hazards.
3. Supervise and check the implementation of hazardous work management regulations.
4. Responsible for the company’s solid waste management and control, environmental monitoring, Emission Declaration, etc.
5. Suppliers and PPE management.

Job Requirements

1. Bachelor or above level in safety, environment, engineering and medicine discipline.
2. Minimum of 2 years’ experience in environment, occupational health and safety, give to priority to certificated safety engineer.
3. Familiar with environment, occupational health and safety management systems, such as ISO14001 and ISO45001.
4. Strong sense of responsibility, outgoing personality, clear language expression, strong communication ability, able to mobilize all resources to complete the work.
5. Excellent English communication skills.

Department: DS MFG /Location: Wuhan, China

Job Responsibilities

1. Participate in the daily activities of the Cell Culture Manufacturing Group. Apply proper PPE (Personal Protective Equipment) to all work in the facility;
2. Participate in the evaluation of new technology, new production process and new production technology;
3. Escalate process issues as necessary to ensure resolution.
4. Author MFG-CC GMP documents, ensure GMP training requirements are complete and current.
5. Familiar with the handle process of quality events such as deviation, CAPA and change control.
6. Ensure operations strictly adhere to all SOPs and cGMP/Quality requirements.
7. 
Ensure all work is performed in safe manner, the operation complies with EHS requirements and meets the specifications for each service request.
8. Production process monitoring ，review documentation and check all calculations (e.g. batch records, labels, equipment reading).
9. Clean and maintain the GMP facility and production equipment, maintenance of environmental and personal hygiene.
10. Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams.

Job Requirements

1. College Degree in Biochemistry, Cell biology, Microbiology，Fermentation engineering，Life Sciences or relevant background.
2. Basic knowledge and understanding of biopharmaceutical technology, especially the process of monoclonal antibodies or recombinant fusion protein drugs.
3. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
4. Communicate effectively and work professionally in a team environment.
5. Familiarity of computer-based systems.
6. Must be flexible to work on any shift (day, night, weekend) and able to work prolong durations on your feet.

Department: DS MFG /Location: Wuhan, China

Job Responsibilities

1. Participate in the daily activities of the purification Manufacturing Group. Apply proper PPE (Personal Protective Equipment) to all work in the facility.
2. Participate in the evaluation of new technology, new production process and new production technology.
3. Escalate process issues as necessary to ensure resolution.
4. Author MGF-DSP GMP documents, ensure GMP training requirements are complete and current.
5. Familiar with the handle process of quality events such as deviation, CAPA and change control.
6. Ensure operations strictly adhere to all SOPs and cGMP/Quality requirements.
7. Ensure all work is performed in safe manner, the operation complies with EHS requirements and meets the specifications for each service request.
8. Clean and maintain the GMP facility and production equipment, maintenance of environmental and personal hygiene
9. Participate in the internal auditing program for company as required. Serve as department representative on cross-functional teams.

Job Requirements

1. College degree or above, major in chemistry, chemical engineering, life sciences or related fields.
2. Basic knowledge and understanding of biopharmaceutical technology, especially the process of monoclonal antibodies or recombinant fusion protein drugs.
3. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
4. Communicate effectively and work professionally in a team environment.
5. Familiarity of computer-based systems.
6. Must be flexible to work on any shift (day, night, weekend) and able to work prolong durations on your feet.

Department: DS MSAT/Location: Wuhan, China

Job Responsibilities

1. Responsible for mammalian cell culture in the shake flask; Familiar with cell thawing, inoculation, subculture and counting.
2. Familiar with cell banking process; Perform cell growth and viability test for the cell bank.
3. Understand the cell culture process development and optimization, including the culture medium screening, process development in shake flask and small bioreactor, and the process parameters optimization; Participate in process scale-up and process characterization study.
4. Responsible for experimental data recording, results analysis and report preparation.
5. Responsible for the maintenance of the daily used equipment and writting the SOP about equipment operation and maintenance.
6. Other related work arranged by team leader/superior supervisor.

Job Requirements

1. Master in Biopharmaceutical, Cell biology, Molecular biology, Biochemistry, Microbiology and Fermentation engineering, or related discipline with 3 years of experience focused on mammalian cell culture process development for the production of therapeutic proteins.
2. Have solid professional knowledge and understand the basic principles of mammalian cell culture processes.
3. Familiar with operating various bioreactor system and disposable bioreactors.
4. Be good at communicating, have team work sprit and the ability to coordinate.
5. Be capable of reading and writing in both Chinese and English.
6. Hard working attitude, and the ability to work well under pressure.

Department: PM /Location: Wuhan, China

Job Responsibilities

1. Responsible for project life cycle management, project schedule tracking and maintenance, project communication and coordination.
2. Coordinate each department internally, organize internal CMC meeting regularly, track the progress and the completion of action items, and ensure the smooth implementation of each project.
3. Communicate with customers externally, coordinate and manage the problems of both parties in customer projects and feed back to internal departments in time.
4. Be responsible for the project implementation management, find and deal with the problems in the project development, organize the members of the project team to study and put forward reasonable solutions.
5. Write internal and external meeting minutes, project progress summary and business letters during the project.
6. Actively maintain the relationship with customers and keep good cooperation between the company and customers.
7. Assist BD and FA department to complete business work.
8. Other work arranged by superior leaders.

Job Requirements

1. Bachelor degree or above, major in biopharmaceutical or other related fields.
2. At least 5 years of bachelor’s degree and 3 years of master’s degree in biomedicine, at least 1 year of project management experience, familiar with biomedicine industry, cdmo experience is preferred.
3. Experience in R & D, quality, production, project management, registration and regulation of Biopharmaceutical Enterprises is preferred.
4. Have a good sense of service, customer-centric, proactive, result oriented, hardworking.
5. Good professional ethics, good organization and coordination, resource integration ability, good at communication, negotiation and public relations
6. Strong ability to work independently and resist setbacks.
7. Good English listening, speaking, reading and writing skills.

Department: CSV&IT /Location: Wuhan, China

Job Responsibilities

1. Maintaining CSV policies and procedures to align with GAMP, PDA and PIC/S guidance.
2. Collaborating with GMP functional departments to ensuring the computer systems are validated in accordance with CSV policies and procedures.
3. Providing guidance for validation activities of computer systems to functional SMEs.
4. Representing as the CSV Subject Matter Expert during the regulatory audits.
5. Representing as the CSV lead in the IT GMP systems projects to ensuring that the GMP projects implementation and deliverables meeting CSV policies and procedures. GMP systems include Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Chromatography Data System (CDS), Computerized Maintenance Management System (CMMS), Learning Management System (LMS) etc.
6. Preparing and reviewing of CSV documents e.g. validation plan, URS, specifications, testing protocols and reports and validation summary report and associated SOPs, deviations and change controls and assessments.
7. Conducting training for the computer systems validation general awareness and processes.
8. Working with GMP functions to ensure they are inspection ready for their regulated computer systems and also conducting internal audits on the computer systems to ensure compliance.
9. Working with vendors to ensure their deliverables complies with policies and procedures.
10. Supporting the existing computer systems periodic reviews and remediation activities.
11. Supporting CSV activities for existing business systems operational activities inclusive of CAPA, deviations, changes and upgrades.
12. Other work arranged by superior leaders.

Job Requirements

1. Bachelor’s Degree in Computer Science, Engineering, Pharmaceutical Sciences, or a related scientific discipline required.
2. 2 to 5 years’ CSV or validation working experience in a regulated environment. Working experience in the pharmaceutical or medical device industries is an added advantage.
3. The ability to effectively prioritize and manage multiple project workloads.
4. Good interpersonal and teamwork skills.

Department: QC /Location: Wuhan, China

Job Responsibilities

1. Perform routine walk-through and regular internal check in QC, to ensure compliance and data integrity.
2. Prepare/revise quality system document, instrument SOP, etc in QC.
3. Handle of compliance related deviation, change control and CAPA in QC.
4. Coordinate/hold internal and external audit to QC.
5. Conduct training on GMP knowledge for QC.

Job Requirements

1. Major in pharmaceutics or other related discipline, two years or more experience in pharmaceutical manufacturing QA/QC.
2. Familiar with GMP, ChP, USP, EP.
3. Fluent English reading and writing skills.
4. Good communication, coordination skills and resilient.

Department: PSG/Location: Wuhan, China

Job Responsibilities

1. Participate in protein physicochemical analysis, including HPLC related analytical method and CE related method，protein content by UV, etc.
2. Participate in analytical method development, qualification and method transfer.
3. Per SOPs, perform routine analysis of samples of process development from MSAT and other non-GMP samples, including in-process samples.
4. Provide analytical technical support to upstream/downstream process development groups during process development and trouble shooting. Support formulation development, tech transfer and scale-up activities.
5. Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, and etc.
6. Conduct the stability study, including long term, accelerated and forced degradation stability tests.
7. Write and review IND, BLA and other regulatory documents.
8. Perform analytical data analysis, data review and trending analysis.
9. Other work arranged by superior leaders.

Job Requirements

1. Bachelor‘s or Master’s degree in chemistry, biology, life sciences or related disciplines, analytical experience in biopharmaceutical industry is preferred.
2. Be familiar with equipment for protein/biologics analysis, such as UV spectrometer, SoloVPE, HPLC, CE, osmometer, CD, DSC, HIAC, Karl Fischer and etc.
3. Be familiar with analytical method development, qualification, validation and method transfer of physicochemical tests.
4. Understand ICH，ChP regulations and guidelines.

Department: F&A/Location: Wuhan, China

Job Responsibilities

1. Preparing documents requested by bank for payment monthly.
2. Examine and verify the payments documents according to the financial system, and check the payments authenticity, validity and integrity of the original vouchers.
3. Assisting prepare data base for fund plan, fund analysis, cash flow and cash projection.
4. Assisting contacting with financial institutions, credit Banks, and other related government department.
5. Go out when necessary (tax bureau, bank, etc.).
6. Assisting accountant to prepare monthly closing (Responsible for donging payment list and check bank statement on SAP).
7. Responsible for Finishing Bank Reconciliation each month.
8. Statement Assisting to sort out all kinds of audit materials.
9. Sorting and Filing financial documents

Job Requirements

1. Bachelor degree or above, major in finance or related, accounting qualification certificate is required.
2. Two years or more working experience is required.
3. Skilled in using financial and office software.
4. Serious and responsible work, proactive, strong sense of responsibility, good learning ability.
5. Have basic English listening, speaking, reading and writing skills.

Department: EHS /Location: Wuhan, China

Job Responsibilities

1. Responsible for the establishment of environmental management system, supervision of implementation and improvement.
2. Responsible for the collection of laws, regulations and standards related to environmental protection, identify and organize the implementation of relevant requirements to ensure compliance.
3. Responsible for the handling and management of legal procedures (licenses) for environmental protection, such as environmental impact assessment, environmental monitoring, and pollutant discharge permits.
4. Responsible for organizing the technical management of waste water and waste gas treatment, upgrading and improvement of environmental protection facilities.
5. Supervise and manage the on-site sewage operation to ensure that the discharge standards are up to standard.
6. Responsible for the company’s solid waste and hazardous waste control, and legal compliance disposal.
7. Responsible for other related environmental management work of the company.

Job Requirements

1. Bachelor degree or above, major in environment or environment related.
2. At least three years working experience in environmental protection management.
3. Familiar with the sewage treatment process of medicine and food industry, understand the treatment technology of wastewater and waste gas, and have some experience in improving environmental protection facilities.
4. Familiar with national and local environmental protection laws, regulations and common rules and regulations, familiar with environmental protection related business work flow.
5. Familiar with ISO14001 environmental management system.
6. Strong sense of responsibility, strong problem analysis and solving skills.

Department: F&A /Location: Wuhan, China

Job Responsibilities

1. Responsible for the accounting of accounts payable in fixed assets, check and clean up the accounts of related subjects.
2. Examine and verify the documents payable according to the financial system, and check the authenticity, validity and integrity of the original vouchers.
3. Responsible for regular inventory of fixed assets.
4. Track the use of annual budget of fixed assets and issue relevant analysis report.
5. For the company’s large-scale procurement project preparation and real-time update of the project schedule control table.
6. Reconcile accounts with suppliers on a regular basis.
7. Understand and be familiar with the progress of the company’s existing projects, and communicate with relevant departments in time to ensure the timeliness of invoicing.
8. Prepare AR control table, to assist the relevant departments to recover the overdue or overdue funds as soon as possible.

Job Requirements

1. Bachelor degree or above, major in finance or related, accounting qualification certificate is required.
2. Three years or more working experience is required.
3. Experience in using SAP is preferred.
4. English must be CET-4 or above.

Department:PSG/Location: Wuhan, China

Job Responsibilities

1. Be responsible to use LC-MS（Thermo Orbitrap QE or others）for protein physicochemical characterization study.
2. Perform Mass Spec data analysis, data review and trending analysis.
3. Provide analytical technical support to cell culture, purification as well as formulation groups to solve challenging technical issues.
4. Participate in protein physicochemical analysis（including purity testing（by HPLC,CE）, concentration testing，etc）, as necessary.
5. Perform technical writing assignments such as SOPs, protocols, reports, risk assessments, laboratory investigations, etc.
6. Write and review IND, BLA and other regulatory documents.

Job Requirements

1. Master’s in chemistry, biochemistry, biology or related disciplines with 2-3 years’ experience in MS application for macromolecular in biotech pharmaceutical industry, or Doctor’s degree with relative experience.
2. Be richly experienced to use LC-MS for protein physicochemical characterization study.
3. Experience with other analytical methods.
4. Understand ICH，ChP regulations and guidelines.

Department: F&A/Location: Wuhan, China

Job Responsibilities

1. Responsible for invoice verification of inventory in the system, and verify the true validity of relevant documents.
2. Regular inventory.
3. Check the timeliness and correctness of material acquisition.
4. Follow up the status of production orders, including receiving materials from BoM, timely reporting monthly and technical fulfillment of production orders.
5. Confirm the update of the project schedule with PM every month and send it to HR, in time to check the man-hours maintained by HR into the system.
6. Follow up the maintenance and technical completion of WBS in the system.
7. Month-end cost carryover (CO module).
8. Complete other tasks assigned by the leader.

Job Requirements

1. Bachelor degree or above, major in finance or related, accounting qualification certificate is required.
2. Five years or more working experience is required.
3. Experience in using SAP is preferred.
4. English must be CET-4 or above

Department: ENG/Location: Wuhan, China

Job Responsibilities

1. Responsible for receiving and archiving equipment documents, engineering drawings and various records, and establishing GEP document management system and equipment archives.
2. Responsible for management of spare parts, including purchase, storage, bookkeeping, inventory, etc.
3. Participate the development of company training plan and supervise the training implementation process.
4. Regularly report documents and spare parts management to superiors, and complete other tasks assigned by dept.

Job Requirements

1. Junior college degree or above in engineering or related field.
2. Proficient in computer operation skills, familiar with document management or spare parts management experience.
3. Good English reading and writing skills.
4. Careful working attitude, good sense of responsibility, strong confidentiality concept.

Department: QC /Location: Wuhan, China

Job Responsibilities

1. Understand technical aspects of the job, best practices, and adhere to cGMP compliance.
2. Provide daily operation support in QC laboratory.
3. Develop and qualify potency assay and impurity assays such as HCP, DNA, and Residual ProA methods to implement at GMP QC groups following ICH/USP/EP/CP guidelines.
4. Perform analysis of in-process and finished formulations according to SOPs.
5. Work to relevant cGMP standards testing in process checks and stability samples.
6. Develop and implement all necessary SOPs.
7. Perform moderate data analysis and trending; document work according to GMP and notify management.
8. Any other tasks as assigned by the supervisor.

Job Requirements

1. Bachelor’s degree in a scientific discipline with 4+ years’ experience in quality control systems, or Master’s degree with 2+ years’ experience.
2. Strong background in standard and specialized methodologies for biologics products.
3. Understanding of FDA and ICH guidelines as well as GLP/GMP principles associated with analytical development.
4. Understanding of the basic statistics required in data analysis.
5. Experience developing bioassays and biophysical potency assays.
6. Experience developing process impurity assays such as HCP, Residual DNA, and Residual ProA methods is preferred.
7. Excellent oral and written communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory, ability to write technical documents and statistical analysis of QC data.

Department: QC /Location: Wuhan, China

Job Responsibilities

1. Understand technical aspects of the job, best practices, and adhere to cGMP compliance.
2. Perform the Environmental Monitoring Program to include system implementation, Facility Qualification, on-going monitoring (sampling, testing, trending).
3. Essential functions include but are not limited to: Bioburden Analysis, Endotoxin Analysis, Viable and Non-Viable Air sampling and analysis, Surface and Personnel monitoring and analysis, water system sampling and analysis.
4. Training members of the department and other departments as necessary.
5. Determining the acceptability of test results and data generated from routine monitoring of clean rooms or technical studies, and the dissemination of these results.
6. Shipping samples to approved contract labs for microbiological enumeration, identification, sterility and other tests.
7. Develop and implement all necessary SOPs.
8. Any other tasks as assigned by the supervisor.

Job Requirements

1. High diploma’s degree or above in a pharmaceutical, chemical or biological discipline.
2. Strong background in standard and specialized methodologies for biologics products preferred.
3. Thorough knowledge of GMP regulations and documentation.
4. Understanding of the basic statistics required in data analysis.
5. Preferably with excellent oral and written communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory, ability to write technical documents.

Department: QC /Location: Wuhan, China

Job Responsibilities

1. Maintain laboratory information management system (LIMS) for QC.
2. Perform routine walk-through and regular internal check in QC, to ensure compliance and data integrity.
3. Quality system document, instrument SOP, etc in QC.
4. Handle of compliance related deviation, change control and CAPA in QC.

Job Requirements

1. Major in pharmaceutics or other related discipline, two years or more experience in pharmaceutical manufacturing QA/QC. Hands-on experience with LIMS is preferred.
2. Familiar with GMP, ChP, USP, EP.
3. Fluent English reading and writing skills.
4. Good communication, coordination skills and resilient.
5. Well versed in desktop software use.
6. Familiar with ISO14001 environmental management system.
7. Strong sense of responsibility, strong problem analysis and solving skills.

Department: QC /Location: Wuhan, China

Job Responsibilities

1. Provide daily operation support and service in QC laboratory, including consumable procurement and inventory check, electronic data backup, training coordination, computerized system time synchronization, software password change notification, lab coat management, etc.
2. Routine lab compliance check, including GDP, equipment validation status, material expiration checking, etc.
3. Leading the team for QC equipment lifecycle management.
4. Collaborate with EHS department to manage laboratory safety.
5. Any other tasks as assigned by the manager.

Job Requirements

1. High diploma degree in a scientific discipline.
2. Excellent planning, communication and problem solving capacity.

Department: QC /Location: Wuhan, China

Job Responsibilities

1. Develop and maintain a robust and stable Raw Material team, with high productivity.
2. Closely monitor the raw material testing status, proactively identify and solve any problem or risk which may cause the delay of raw material release.
3. Ensure all the sampling and testing are completed according to relevant SOP and GMP standard.
4. Lead all the OOS investigation, deviation investigation, close CAPA, change control in a timely manner.
5. Host internal or outside audit.
6. Continuously improve lab operation compliance, efficiency, reduce cost.
7. Any other tasks as assigned by the manager.

Job Requirements

1. Bachelor’s degree in chemistry, biology or pharmaceutics discipline with 5+ years’ experience in pharmaceutical company quality control department, or Master’s degree with 3+ years’ experience.
2. Familiar with USP, EP, JP and ChP requirement on drug substance, excipient, packaging material.
3. Well versed in chemistry or microbiology based testing, with hands-on experience.
4. Thorough knowledge of NMPA, EMA and US FDA GMP practices and regulations.
5. Excellent oral and written communication skills in English.

Department: QC /Location: Wuhan, China

Job Responsibilities

1. Perform physical-chemical analysis of in-process sample, drug substance, drug product and stability sample according to SOPs.
2. Participate in method transfer, verification and method validation activities which include protocol drafting, execution, data analysis and completing the summary report.
3. Create and implement all necessary SOPs.
4. Understand technical aspects of the job, best practices, and adhere to cGMP compliance.
5. Provide daily operation support in QC laboratory, such as equipment maintenance, 5S management.
6. Other work arranged by superior leaders.

Job Requirements

1. Master in a related scientific discipline (Chemistry, analytical-chemistry or equivalent scientific experience if all other criteria are met) with 1+ years’ experience or Bachelor in a related scientific discipline, with 3+ years’ experience.
2. Extensive experiences in analytical testing for protein analysis, such as HPLC, CE, MS, iCE3, UV, etc.
3. Extensive experience in method development, qualification, validation and method transfer of physical-chemical methods.
4. In-depth knowledge of scientific, analytical, manufacturing and regulatory principles.
5. Work in GMP environment, and experienced in GMP documentation, testing and investigations.
6. Good English listening, speaking, reading and writing skills.