Executive - Production Mammalian
Lupin · Pune/Pimpri Chinchwad et périphérie
Job description
About the role
We are seeking an Executive to lead the mammalian production unit, overseeing shift operations and mentoring the downstream team in a GMP‑compliant environment.
Key responsibilities
- Supervise shift operations, lead, train and mentor the downstream team.
- Prepare buffers for small‑scale and large‑scale runs and perform IPQC on buffer and protein intermediate samples.
- Conduct cleaning‑in‑place (CIP) and steam‑in‑place (SIP) for chromatography, TFF systems and process vessels.
- Operate chromatography, TFF, virus filtration and DS filtration equipment for protein purification.
- Monitor critical process parameters throughout production batches.
- Develop, execute and maintain SOPs, BPRs, qualification and validation documents.
- Coordinate daily activities with QC/QA teams and review completed BPRs.
- Plan and maintain raw material and consumable inventories.
- Operate and maintain sterile autoclave and decontamination equipment.
- Identify, initiate and support investigation of facility‑related deviations.
- Prepare GMP documentation including qualification protocols, validation plans and media/cell‑culture procedures.
Required profile
- 4–8 years of relevant experience in mammalian bioprocessing.
- Bachelor’s (B.Tech) in Biotechnology or related field; postgraduate degree in Biotechnology preferred.
- Demonstrated result orientation, strategic agility, innovation, creativity and customer‑centric mindset.
Required skills
- Buffer preparation
- In‑process quality control (IPQC)
- Cleaning‑in‑place (CIP)
- Steam‑in‑place (SIP)
- Chromatography system operation
- Tangential flow filtration (TFF) operation
- Virus filtration
- Depth filtration (DS) for protein purification
- SOP development and maintenance
- Batch process record (BPR) execution
- Qualification and validation documentation
- QC/QA coordination
- Raw material and consumable inventory management
- Autoclave operation and maintenance
- Deviation identification and investigation support
- GMP documentation preparation
- Media preparation and cell‑culture operations
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Published 1 month ago
Expires 6 days from now
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Lupin
Pune/Pimpri Chinchwad et périphérie
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