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Executive – Production Mammalian

Lupin · Pune/Pimpri Chinchwad et périphérie

New
Mid 🇬🇧 English
Buffer preparation IPQC operation CIP of chromatography systems SIP of TFF systems Operation of chromatography systems DS filtration Deviation identification

Job description

About the role

We are seeking an Executive to lead the mammalian production unit, overseeing downstream operations and ensuring high‑quality protein manufacturing. The role combines shift supervision, technical expertise, and cross‑functional coordination within a GMP environment.

Key responsibilities

  • Supervise shift activities, train and mentor downstream team members.
  • Prepare buffers for small‑ and large‑scale runs and perform IPQC on buffer and protein intermediates.
  • Conduct CIP and SIP of chromatography, TFF systems and process vessels.
  • Operate chromatography, TFF, virus filtration and DS filtration systems for protein purification.
  • Monitor critical process parameters and maintain SOPs, BPRs, qualification and validation documents.
  • Coordinate daily production activities with QC/QA teams and review executed BPRs.
  • Plan and maintain raw material and consumable inventories.
  • Operate and maintain sterile autoclave and decontamination equipment.
  • Identify, initiate and assist investigations of facility‑related deviations.
  • Prepare GMP documentation such as qualification protocols for media preparation and cell culture operations.

Required profile

  • 3‑8 years of experience in mammalian cell manufacturing.
  • B.Tech or postgraduate degree in Biotechnology.
  • Strong understanding of GMP regulations and downstream processing.
  • Ability to lead teams, manage documentation and work with cross‑functional groups.

Required skills

  • Buffer preparation for bioprocessing.
  • IPQC of buffer and protein intermediates.
  • CIP and SIP of chromatography and TFF systems.
  • Operation of chromatography, TFF, virus filtration and DS filtration equipment.
  • Monitoring of key process parameters.
  • Creation and maintenance of SOPs, BPRs, qualification and validation protocols.
  • Inventory planning for raw materials and consumables.
  • Sterile autoclave operation and decontamination.
  • Deviation identification and investigation support.
  • GMP document preparation for media and cell culture processes.

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Published 1 week ago

Expires 1 month from now

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Lupin

Pune/Pimpri Chinchwad et périphérie