Department: Protein Science / Location: Wuhan, China

Job Responsibilities

1. Lead Cell Culture group of Process Development, Supervise personnel, and organize/plan resources;
2. Execute and evaluate laboratory-scale cell culture experiments in order to develop robust processes suitable for GMP clinical and commercial manufacturing;
3. Make use of sound statistical DOE-based strategy in order to understand deeply the impact of cell culture process parameters on target product quality;
4. Write and review necessary process development related documents including process development reports, technical transfer reports, and characterization and validation protocols and electronic data histories;
5. Write and revise protocols, procedures, reports, batch record and other process related documentation as necessary to support GMP manufacturing operations;
6. Develop employee’s knowledge, understanding, and skills to improve performance and expand abilities;
7. Ensure employees remain current with all department and site training requirement;
8. Taking an active role in incident inquiry, investigation, and reporting;
9. Communicate the group’s status, experiment data and feedback to management in a timely manner;
10. Other work arranged by superior leaders.

Job Requirements

1. Ph.D. or MS in Chemical/Biochemical Engineering, Biochemistry, Cell Biology, or related discipline with at least 10 years of experience focused on mammalian cell culture process development for the production of therapeutic proteins
2. Familiarity with laboratory procedures and operations including set up and operating shake flasks , lab scale bioreactors and pilot scale disposable bioreactors and associated analytical equipment used for mammalian cell culture processes.
3. Experience with medium selection, process optimization and process scale up.
4. Experience with authoring IND, CTA, and BLA regulatory documents.
5. Understanding of the application of GMP in the development and production process.
6. Capable of writing details reports and summaries and exhibit detail oriented documentation skills;
7. Communicate effectively and work professionally in a team environment;
8. Highly skilled in Word, Excel, and PowerPoint; experience with statistical DOE software;
9. Excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving complicated issues.

Department: BD / Location: China

Job Responsibilities

1. Develop strategic framework to analyze the company＇s existing business as well as new market opportunities. Set and track individual team objectives detailing expected revenue goals. Manage all activities to maximize attainment of forecasted sales goals; directs resources and assigned budget.
2. Lead strategic BD efforts, including scanning the market, establishing target lists, summarizing key targets, fit with company strategy, estimates of target size market size/growth.
3. Plans, organizes, provides market intelligence, communications, processes, leadership to achieve operational, tactical, business development objectives;
4. Effectively manages Business Development team; monitors performance, conducts performance reviews. Develop and communicate clearly defined objectives for the team and hold them accountable for achievement of these objectives. Provides direction and support to the team on weekly & monthly basis to achieve the agreed objectives.
5. Responsible for meeting expense budgets. Coordinate budgets, develop and update forecasts, and provide reports as needed or requested.
6. Drive a strong cross functional team mentality within and between teams, especially between the account managers.
7. Performs other duties as assigned, e.g. preparing proposals, approving quotations, representing company at trade shows, conferences, etc.
8. Provides appropriate coaching and performance feedback to all direct reports and assures that all team members are being developed.

Job Requirements

1. Bachelor degree or above in biomedicine, pharmacy, medicine, chemistry, medical English or marketing;
2. Those with more than ten years experience in the pharmaceutical industry are 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;
7. Good English listening, speaking, reading and writing skills.

Department: Protein Science / Location: Wuhan, China

Job Responsibilities

1. Lead and participate in formulation and drug product (DP) process development and stability assessment activities for biological drugs, such as monoclonal antibody(mAb), bispecific antibodies, recombinant proteins, etc;
2. Independently screen and optimize the formulation and drug product process of different dosage forms based on a comprehensive physicochemical knowledge of therapeutic drugs according to domestic and international quality requirements and GMP requirements;
3. Establish drug product process from pilot scale to commercial scale;
4. Develop the stability program for different products, in different stages;
5. Develop fit-for-purpose analytical methods to support biophysical characterization, formulation and process development, and research stability testing;
6. Conduct formulation research and make relevant original records according to relevant specifications, organize and file data, assist and participate in the preparation of declaration data;
7. Laboratory maintenance, calibration, operation and maintenance of formulation equipment shall be carried out and operated according to SOP;
8. Work closely with relevant departments to ensure the smooth progress of the project;
9. Other work arranged by superior leaders.

Job Requirements

1. Master degree or above in Pharmaceutical Sciences, Biochemistry, Biophysics, Chemistry, Chemical Engineering, or related discipline with at least 6 years of pharmaceutical industry formulation development experience;
2. Strong theoretical knowledge and experience with protein chemistry, biochemical characterization of proteins or other biological drugs;
3. Hands-on experience and trouble-shooting proficiency with applying chromatographic (HPLC/UPLC), visible and subvisible particle analysis, CE and/or other biophysical technics (DLS, DSC, CD, FTIR, AUC, Fluorescence, Raman spectroscopy) for protein characterization are desirable;
4. Active, highly responsible, with team spirit;
5. Good oral and written communication skills in Chinese and English.

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: QC / Location: Wuhan, China

Job Responsibilities

1. Perform the Environmental Monitoring Program to include system implementation, Facility Qualification, on-going monitoring (sampling, testing, trending); Understand technical aspects of the job, best practices, and adhere to cGMP compliance;
2. 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;
3. Determining the acceptability of test results and data generated from routine monitoring of clean rooms or technical studies, and the dissemination of these results;
4. Shipping samples to approved contract labs for microbiological enumeration, identification, sterility and other tests;
5. Develop and implement all necessary SOPs, training members of the department and other departments as necessary;
6. Other work arranged by superior leaders;

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, the basic statistics required in data analysis;
4. Preferably with excellent oral and written communication skills in Chinese and English (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. Provide daily operation support in QC laboratory, understand technical aspects of the job, best practices, and adhere to cGMP compliance.
2. 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.
3. Develop and implement all necessary SOPs, perform analysis of in-process and finished formulations according to SOPs, work to relevant cGMP standards testing in process checks and stability samples,
4. Perform moderate data analysis and trending, document work according to GMP and notify management;
5. Other work arranged by superior leaders;

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; Experience developing bioassays and biophysical potency assays, developing process impurity assays such as HCP, Residual DNA, and Residual ProA methods is preferred;
3. Understanding of FDA and ICH guidelines as well as GLP/GMP principles associated with analytical development, the basic statistics required in data analysis.
4. Highly motivated, flexible, and multi-tasks
5. 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: DS MFG-DSP / 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;
10. Other work arranged by superior leaders;

Job Requirements

1. Bachelor’s Degree in Chemistry, Chemical Engineer, 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;
7. Oral and written communication skills in Chinese and English (Read, Write, Verbal).

Department: DS MFG-USP / 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. Bachelor’s 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;
7. Oral and written communication skills in Chinese and English (Read, Write, Verbal).

Department: F&A / Location: Wuhan, China

Job Responsibilities

1. Responsible for cost and revenue calculation of projects allocated;
2. Responsible for costing track and costing control for each projects;
3. Responsible for preparing for cost analysis report monthly;
4. Responsible for booking cost in ERP/SAP system;
5. Responsible for understanding and consulting the interpretation of national and regional tax policies and regulations and implementation rules, combined with the company’s business planning.
6. Responsible for the company’s tax annual audit and other business work
7. Responsible for the preparation and submission of various tax financial statements, actively coordinate the relationship with local tax, pay attention to the company’s favorable information, and put forward reasonable suggestions;
8. Responsible for the tax invoice application, as well as the company’s various invoices, receipts custody, receipt, payment and other work.
9. Other work arranged by superior leaders.

Job Requirements

1. Bachelor’s degree or above, major in finance, must have a qualification certificate in accounting;
2. 5 years or above related work experience in accounting;
3. Familiar with financial management processes and national fiscal and tax laws and regulations;
4. Skilled in using finance and office software;
5. Good communication skills and strong ability to analyze business date;
6. English level 4 and above is required.

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: DS MSAT Downstrem / Location: Wuhan, China

Job Responsibilities

1. Do the preparatory work before the start of the experiment. (e.g.: the preparation of BR, materials, labels, TAR and so on.);
2. Process scale up from 200L to manufacturing 2000L.Ensure tasks are completed in accordance with approved site procedures, batch records, and protocols；Technology transfer from external part to MSAT;
3. Perform the early and late stage process development and troubleshooting;
4. According to the production process, review and revise the relevant GMP documents;
5. Make the appropriate experimental records during the experiments, cooperate with the teammate to execute protein purification process in accordance with batch record;
6. Freezer management. (Including 4℃，-20℃，-80℃ Freezer), timely completion of qualification and calibration of instruments and equipment;
7. Summary change control of owner each project, Optimize and improve processes, improve efficiency;
8. Participate in a series of related training (operation training and documentation training);
9. Other work arranged by superior leaders.

Job Requirements

1. Master’s Degree in Life Sciences/Chemistry/Pharmacology or Bachelor’s Degree in Life Sciences/Chemistry/Pharmacology and 3+ year of related experience in purification using automated control systems;
2. Thorough knowledge and understanding of biopharmaceutical technology, processes;
3. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills;
4. Familiarity of computer-based systems;
5. Must be flexible to work on any shift (day, night, weekend);
6. Excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory.

Department: DS MSAT-USP / 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 work arranged by superior leaders.

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; Hard working attitude, and the ability to work well under pressure;
5. Be capable of reading and writing in both Chinese and English.

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: 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;
7. Other work arranged by superior leaders.

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; have experience on antibody glycosylation profiling.
3. Experience with other analytical methods, such as CE;
4. Understand ICH, ChP regulations and guidelines;
5. Excellent oral and written communication skills in English.

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: QA / Location: Wuhan, China

Job Responsibilities

1. Active participation in compliance and continuous improvement of the Company Quality Management System with specific attention to validation lifecycle processes;
2. Contributing to the safe operation of company’s facilities through personal initiative and adherence with Company procedures, support cleaning and process validation, and ensure zero lost-time injuries;
3. Lead validation risk assessment workshops to document failure modes and mechanisms for control of critical-to-quality attributes, draft system and component criticality assessments;
4. Preparing validation plans and protocols: DQ, IQ, OQ, and PQ;
5. Reviewing specifications for compliance with company quality standards and performance criteria;
6. Maintaining the validated state of direct-impact systems in compliance with Good Manufacturing Practice (GMP);
7. Review of Factory Acceptance and Site Acceptance Test (FAT and SAT) documents prepared by Vendors;
8. Coordinating preparation of Process, Cleaning, and Computerized System Validation Plans in collaboration with Subject Matter Experts;
9. Executing validation protocols in compliance with Good Documentation Practice and approved procedures. Preparing validation reports;
10. Preparing standard operating procedures and associated records covering the validation lifecycle: risk assessments, URS, FS, DS, Qualification Protocols and Reports;
11. Preparing standard procedures for operation of testing equipment used in validation testing such as KAYE 2000 thermal mapping systems;
12. Identify validation requirements for proposed changes and corrective actions, raising and timely closure of Qualification Deviations;
13. Selection and purchase of equipment and consumables required to execute validation activities;
14. Other work arranged by superior leaders;

Job Requirements

1. Bachelor degree or above, major in mechanical or chemical); plus a minimum of 2 years of experience in validation within pharmaceutical or medical device industries or at least 5 years of pharmaceutical industry experience without formal qualifications experience；preferably experienced in operation of pharmaceutical facilities with exposure to facility start-up;
2. Sound knowledge of Good Engineering Practices encompassing documentation and operation of pharmaceutical facilities. Sound Understanding of Good Manufacturing Practice (GMP);
3. Sound knowledge of the operation of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, and cleanroom HVAC), computerized systems, process equipment, analytical test equipment and DP fill finish equipment (e.g. washing machine, depyrogenation tunnel, and filling machine);
4. Familiar with Good Automated Manufacturing Practice (GAMP);
5. Ideally hands-on experience in thermal mapping of controlled temperature environments and qualification of computerized systems. Preferably Member of ISPE or PDA;
6. Advanced document writing skills using MS Office suite. Eye for detail and preference to work in highly structured manner;
7. Strong communication skills in English and Chinese to engage with personnel across the Company and service providers including understanding of technical documentation in English.

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: PSG / Location: Wuhan, China

Job Responsibilities

1. Participate in the formulation development/optimization and stability evaluation activities of biopharmaceutical preparations and drug product fill & finish, such as monoclonal antibodies, bispecific antibodies, recombinant proteins, etc.;
2. Carry out research and development of macromolecular pharmaceutical preparations in accordance with domestic and international drug quality guidelines and GMP requirements;
3. Standardize and make relevant original records in accordance with the requirements, compile and archive materials and write research reports;
4. Cooperate closely with the work of relevant departments, coordinate project progress and solve related problems;
5. Other work arranged by superior leaders.

Job Requirements

1. Master degree or above in Pharmaceutical Sciences, Biochemistry, Biophysics, Chemistry, Chemical Engineering；
2. Have theoretical knowledge and experience with molecular biology, protein chemistry, biochemical characterization of proteins or other biological drugs;
3. Have the following experimental experience in protein characterization and have some understanding of chromatography(HPLC/UPLC) and protein particulates (HIAC/FlowCam or MFI/SLS) monitoring;
4. Active, highly responsible, with team spirit;
5. Good oral and written communication skills in Chinese and English.

Department: BD / Location: Wuhan, China

Job Responsibilities

1. Responsible for project lifecycle management, project schedule tracking and maintenance, project communication and coordination.
2. Coordinate with various departments internally, organize internal CMC meetings regularly, follow up the progress and completion of action items, and ensure the smooth implementation of each project.
3. Communicate with the customer externally, coordinate and manage the problems of both sides in the customer project and give timely feedback to the internal departments.
4. Responsible for project implementation management, find and deal with problems in project development, organize project team members to conduct research, and put forward reasonable solutions.
5. In the process of writing the project, the minutes of internal and external meetings, the summary of project progress and business letters and other materials.
6. Actively maintain customer relations and maintain a good cooperative relationship between the company and customers.
7. Assist BD and FA to complete the business work.
8. Complete other tasks assigned by superiors.

Job Requirements

1. Bachelor degree or above, major in biopharmaceutical or related.
2. Bachelor degree more than 5 years, master degree more than 3 years biomedical work experience, at least 1 year project management experience, familiar with biomedical industry, CDMO experience is preferred.
3. Experience in R & D, quality, production, project management, registration, laws and regulations of bio-pharmaceutical companies is preferred.
4. Have a good sense of service, customer-centered, proactive, result-oriented, hard-working.
5. Have good professional ethics, good organization and coordination, resource integration skills, good at communication, negotiation and public relations.
6. Strong ability to work independently, strong ability to resist setbacks.
7. Good English listening, speaking, reading and writing skills.

Department: RA / Location: Wuhan, China

Job Responsibilities

1. Write regulatory documents according to internal and external needs.
2. Compile and prepare various registration application documents for drugs, including but not limited to communication meetings, clinical trial applications (CTA), marketing applications (BLA/NDA), annual reports, etc.
3. Interface with NMPA/CDE, FDA, EMA, in strong collaboration with other department/team to ensure the efficient implementation of relevant work.
4. Actively involved and coordinate relevant activities in the submission process to ensure the application can be approved quickly and smoothly.
5. Manage contractors/consultants as needed.
6. Assist in internal and cross-functional regulatory development policy.
7. Execute other duties as may be required by RA.

Job Requirements

1. Bachelor degree or higher in a scientific discipline
2. 2-3 years of experience in the core activities of Regulatory/Technical Development
3. Experience and strong understanding of drug research and development
4. Scientific writing and editing skills are essential (Chinese and English)
5. Critical attention to details
6. Strong knowledge of the regulatory environment, FDA/EMA/NMPA regulations, ICH guidelines, and have the communication ability with drug regulatory authorities
7. Excellent verbal and written communication skills in English and Mandarin
8. Strong individual contributor who also works with teams effectively, including a proven ability to work well under pressure
9. May require travel to 5-10%

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.