Executive / Senior Executive - Downstream Production - Ambernath

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.