Scientist III, Bioassay
US Pharmacopeia
Full time- 6+ years
- Not Disclosed
- Hyderabad, India
- Post Date: Apr 19, 2024
- End Date: Jun 19, 2024
- 6+ years
- Not Disclosed
- Hyderabad, India
- Post Date:Apr 19, 2024
- End Date: Jun 19, 2024
Skills:
- pharma
- Quality control
- Management
Job Description:
Responsibilities
- Performs in vitro cell based assays and binding assays using Biacore.
- Performs PCR, RT-PCR, qPCR, ddPCR and gel electrophoresis etc. for mAbs, vaccine and CGT products·
- Develops and evaluates methods used for the measurement of biological attributes, develops validation protocols, and execute the validation plans. Prepares final report and presents data as applicable
- Evaluates and analyzes scientific reports and identifies next steps and key challenges. Plan and conduct research projects independently
- Works with cross-functional teams within the organization to solve/support both technical and process-related issues.
- Performs peer-review of data along with collaborative test and research reports
- Keeps abreast of current trends and developments in related scientific fields, particularly in functionalm assays, binding assays, impurity analysis in mAbs, CGT and vaccines.
- Demonstrates strong technical skill, interest, and expertise in binding, functional and viral assays
- Actively engages in overall project and ensures own work is aligned with overarching goals
- Shares technical expertise with junior fellow lab staff and serve as a mentor for them
- Seeks out innovative ways to apply knowledge or skills to improve protocols and results
- Assists team lead in planning, implementing, and evaluating laboratory procedures/systems
- Supports in departmental trainings as applicable.
- Attends scientific seminars and conferences
- Follows GLP and QMS practices. Recommend improvement to systems and all other supporting activities as assigned by the team lead. Participates in internal and external audits.
- Aligns with USP's mission, and complies with USP's guidelines and other requirements
- Performs other duties as assigned.
Qualification & Experience
- The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
- M.Sc. in Biochemistry, or related Biological Science field with 6-8 years of Industrial experience in Bio pharmaceutical product development and quality testing, potency assay, mAb functional and binding assays (using Biacore) and molecular biology techniques. Able to analyze and interpret data using appropriate statistical software/methods and calculation for relative potency determination.
- An equivalent combination of education and experience may be substituted. Laboratory experience must include expertise developing and validating assays, technology transfer for monoclonal antibodies and vaccine testing, ELISA, advanced PCR techniques, viral assays.
Remove this line later