Description

cGMP experience needed

Cell based potency assay

• Not open for research experience
• Documentation experience, GMP, CBPA, 
• Bachlors degree /masters degree/ PHD degree.
• Cell cuture experience
• Perform cGMP testing
• Gmp compliance
• Bio assay Cell Culture, ELISA, Human cell lines
• Phd candidate will be considered
• No overqualification
• Looking for industry experience

PREFERRED

• Proficiency in TrackWise, Microsoft Project, and Excel.
• Experience in bioassays, Chemi-ELISA preferred.
• Bio assay, western blot are plus

Description: 

• The Senior Quality Control Analyst or scientist II is responsible for conducting the cell-based potency assays(CBPA) of biologics for release and stability of both commercial and late-stage biologics under current good manufacture practice(cGMP).
• He/She will prepare all documentation associated with the cGMP testing and independently or in a team setting execute protocols in support of manufacture of Cient’s biologics product.

The position is responsible for cGMP compliance of the quality control CBPA laboratory, ensuring that all cell Based Potency Assays testing is performed according to the FDA, foreign MOH and Cient requirements. 

• Perform cGMP testing in support of the manufacture of Cient ’s biologics products.
• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
• 3Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections where needed.
• Support new methods validation.
• Perform and execute activities supporting CBPA lab such as equipment validation, equipment preventive maintenance.
• Generate and update SOPs.

Regulated Responsibilities (including cGMP and EHS):

• Cient is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
• Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications:

• MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.
• Experience with the application of aseptic cell culture, cell banking and 96-well format bioassay techniques for potency determination of proteins and their degradation and modification products.
• Skill in the use of and programming multiple equipment for bioassays, such as Synergy2, Neo2, MSD imager, Luminex Plate reader. Experience in the application of liquid handlers in cell-based assay automation and related software for data analysis is a plus.
• Skills in addition to bioassays including West blot, qPCR, qELISA and antibody conjugation (HRP and biotin) are preferred.
• Ability for technical troubleshooting, in particular, root cause analysis and CAPA development/implementation is a must.
• Proficiency in TrackWise quality system, Microsoft Project, and Excel.
• Experience in working in cGMP regulated environment is required.
• A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
• Well developed written and oral communication skills. Motivate to work in a team environment.
• Consistently deliver on commitments and respond to department needs in a timely and courteous manner.
• Demonstrated knowledge of the use of a continuous improvement methodology in a lab testing environment.