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

1. 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 Non-mAb products.
2. Candidate should have appropriate scientific knowledge of analytical techniques performed during biosimilar product development.
3. 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).
4. Candidate should have experience in monitoring/overlooking instrument qualification and lab set-up.
5. Candidate should be experienced in documentation (Lab notebook, SOPs, MOAs, STPs, DRS etc.), following GDP.
6. 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

1. Provide analytical support during scale-up, global development and technology transfer during product life cycle.
2. Get trained and perform existing analytical methods (HPLC, HCD and ELISA based methods), and generate quality data.
3. Prepare instrument SOPs, IQOQ documents, PV documents, MOA and reports.
4. Involve in equipment qualification.
5. Perform and involve in method development and qualification.
6. Ensure resources are in stock.
7. Ensure instruments are maintained in a qualified state with essential calibrations and performance verification.
8. 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