Executive / Senior Executive - Downstream Production - Ambernath

2 days ago

Thāne, Maharashtra, India Biogenomics Full time

Role & responsibilities

  • Operate and monitor Tangential Flow Filtration (TFF) systems including membrane integrity checks (water permeability, pressure-hold, bubble point tests).
  • Perform Ultrafiltration (UF) and Diafiltration (DF) for protein concentration and buffer exchange.
  • Conduct Ion Exchange Chromatography for protein purification based on charge properties.
  • Independently handle AKTA chromatography systems, BPG glass columns, and SS vessels (500L capacity).
  • Execute RP-HPLC analysis for product quality and purity.
  • Maintain and follow QMS documentation including Change Control, Deviation, SOPs, and Batch Manufacturing Records (BMR).
  • Monitor Transmembrane Pressure (TMP) to ensure consistent membrane performance.
  • Ensure compliance with GMP and safety standards during all operations.
  • Ensure efficient recovery and purification of biologics (e.g., insulin) from upstream processes.
  • Troubleshoot and optimize purification steps to improve yield and product quality.
  • Collaborate with cross-functional teams including upstream, quality, and analytical departments.
  • Maintain equipment hygiene and readiness for production batches.
  • Participate in process validation, scale-up, and technology transfer activities.
  • Support continuous improvement initiatives and maintain production documentation.
  • Perform any and all activities involved in operations of Downstream Production.
  • Handling Downstream equipment and instruments such as AKTA Explorer and
  • Basic, Column Packing, Preparative RP-HPLC system, Analytical HPLC system,
  • Diafiltration System, Spectrophotometer, Freeze Dryer system, SDS PAGE
  • Analysis and MALDI-TOF
  • Providing assistance on on-going projects in DS.
  • Assisting in Downstream related Quality Management Systems.
  • All relevant documentation and capturing generated data or evidence Execution
  • of batch as per schedule timeline
  • Work in rotational shifts as per batch requirements
  • Handling any additional responsibilities given by reporting manager.

Required Skills:

  • Hands-on experience with AKTA systems, TFF, BPG columns, and large-scale SS vessels.
  • Strong understanding of chromatography principles and membrane-based separation techniques.
  • Proficiency in RP-HPLC operation and troubleshooting.
  • Familiarity with QMS documentation practices.
  • Ability to work independently and collaboratively in a regulated manufacturing environment.

Preferred candidate profile:

Minimum 3+ years of experience in Downstream Production with experience in independently handling AKTA, TFF, BPG Glass Columns, working on SS Vessels, Production activities.

Must be ready to work in rotational shifts.

Ready to travel / relocate to Ambernath, Thane district, Maharashtra.

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