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Executive - Production Mammalian

Lupin · Pune/Pimpri Chinchwad et périphérie

Mid 🇬🇧 English
Buffer preparation Virus filtration

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

40 views · 0 interested

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Lupin

Pune/Pimpri Chinchwad et périphérie