Job Title: Executive - MSAT (ADL)
Competencies
Purpose of Job
To work in MSAT-ADL team and provide analytical support in method development, method qualification, in process/DS testing during scale-up, global development and technology transfer throughout product life cycle.
Skill Required
- Candidate must have 2 to 4 years of experience working in Analytical lab set-up (QC or R&D) on biosimilar product(s), preferably on both mAb and other protein products.
- Candidate should have appropriate scientific knowledge of analytical techniques performed during biosimilar product development.
- Candidate should have expertise in HPLC (routine operation, troubleshooting and maintenance), along with sufficient hands-on experience in performing HPLC based analysis (RP-HPLC, SE-HPLC, IEX-HPLC, N-glycan analysis).
- Candidate should have experience in monitoring/overlooking instrument qualification and lab set-up.
- Candidate should be experienced in documentation (Lab notebook, SOPs, MOAs, STPs, DRS etc.), following GDP.
- Candidates with hands-on experience in performing HCD and ELISA based methods (i.e. HCP, residual Pro A etc.) shall be preferred.
Roles and Responsibilites
- Provide analytical support during scale-up, global development and technology transfer during product life cycle.
- Get trained and perform existing analytical methods (HPLC, HCD and ELISA based methods), and generate quality data.
- Prepare instrument SOPs, IQOQ documents, PV documents, MOA and reports.
- Involve in equipment qualification.
- Perform and involve in method development and qualification.
- Ensure resources are in stock.
- Ensure instruments are maintained in a qualified state with essential calibrations and performance verification.
Assist superior in preparing lab budget, planning, evaluating and implementing lab procedures and systems.
Qualification Required
Mtech or MSc.
Relevant skills / Industry experience
2 to 4 years of experience in working with analytical lab (QC or R&D, Biopharma industry)
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213