Greetings!!!!!
Position: Assistant Manager / Deputy Manager Upstream Production
Location: Maharashtra
Department: Production Upstream
Experience: 814 Years
About the Role:
We are looking for an experienced Upstream Production qualified for a Drug Substance Biologics Manufacturing facility. The ideal candidate should have hands-on experience in microbial/biologics manufacturing, fermentation, bioreactor operations and GMP/QMS
.
Key Responsibilities:
- Execute upstream manufacturing activities as per BMR/MFR and SOPs.
- Handle microbial/biologics fermentation and bioreactor operations.
- Experience in MCB/WCB, seed culture/inoculum preparation, media/feed preparation.
- Handle CIP/SIP and manufacturing equipment.
- Ensure cGMP compliance and timely completion/review of batch manufacturing records.
- Handle QMS activities including Deviation, CAPA, Change Control and OOS.
- Support validation/revalidation activities including URS, IQ, OQ and PQ.
- Support batch planning, manpower planning and shift scheduling.
- Coordinate with QA, QC, Engineering, Validation and other cross-functional teams.
- Support audits, self-inspection and regulatory compliance.
- Train and supervise production team members.
- Experience with SAP/MES/TrackWise or similar digital systems will be an advantage.
Required Skills:
- Upstream Biologics Manufacturing
- Microbial Fermentation
- Fermentation / Bioreactor
- Vaccine / Recombinant Protein / Biologics Manufacturing
- GMP / cGMP
- QMS
- MCB / WCB
- CIP / SIP
- BMR / MFR / SOP
- Deviation / CAPA / Change Control
- Validation / Qualification
- Team Handling
Education: B.Tech / B.E. / M.Sc. / M.Tech in Biotechnology, Biochemistry, Microbiology or related Life Sciences discipline.
Preferred Candidate Profile:
Candidates with hands-on experience in commercial-scale microbial fermentation or upstream biologics manufacturing from established Biopharma or Biologics manufacturing environments are preferred.
Interested Candidates Kindly share your updated cv to
[email protected]
📌 Assistant Manager / Deputy Manager_ Upstream Production _Maharashtra (Navi Mumbai)
🏢 BVR People Consulting
📍 Navi Mumbai