Department:- Bioassay Manager
- Take full responsibility for deliverables of the QC Bioassay team, which includes routine testing to support product release, stability, and process validations.
- Coordinate routine and non-routine analyses of test articles by methods such as residual impurity by ELISA and qPCR, potency determination by ELISA and cell-based methods. Manage the critical reagent, reference standard, and product control qualifications.
- Serve as a technical expert on the bioassay related methods performed in the group and the results obtained. Strong knowledge of analytical trending programs to evaluate and investigate data to detect product or method-related trends.
- Monitor workload distribution, prioritize as needed and ensure completion of all tasks.
- Identify analytical projects required to achieve group and corporate objectives. Plan and coordinate implementation of desired outcome(s).
- Work independently but ensure communication of critical information upward with agreement from senior management for key decision-making.
- Evaluate, coach and manage personnel performance. Set team group objectives, monitor progress, and be accountable to commitments.
Department:- Bioassay/Plate Based Assays
Qualification:- MSC in Biochemistry/Biotechnology
Experience:- 1-5 years
No. Of position:- 6
- Candidate should be MSC in Biochemistry/Biotechnology and from Biopharma industry.
- Should have experience in all QC Bioassays optimization/ validations and routine use.
- Should have experience in plate based assays, ELISA, RTPCR, HCP HCDNA
- Must be aware of all QMS activities
- Should have experience in QC documentation/LIMS.
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