Biopharmaceutical Production Executive – Drug Substance

Job Purpose

The Associate is responsible for supporting the end-to-end manufacturing operations within the
Drug Substance (DS)
department — ensuring compliance with
Good Manufacturing Practices (GMP)
, timely execution of production batches, effective documentation, equipment qualification, and adherence to EHS and quality standards. The role contributes directly to achieving high process robustness, consistent batch performance, and continuous improvement in production efficiency and quality.

Job Responsibilities

• Monitor and ensure compliance with
  GMP
  requirements across all Drug Substance operations.
• Ensure batches are manufactured as per the
  approved production plan
  without delays.
• Ensure strict
  adherence to SOPs
  and that the team follows defined procedures.
• Manage
  production planning and inventory control
  to ensure timely availability of raw materials prior to batch start.
• Coordinate
  DS dispensing activities
  with the team and ensure timely release of batches.
• Review and submit all
  GMP documentation
  to QA in accordance with established SLAs.
• Lead or support
  investigation of deviations, OOS, OOT, and non-conformances
  , implement CAPA, and ensure timely closure as per SLA.
• Ensure all production equipment remains in
  qualified status
  in coordination with cross-functional teams (CFT).
• Coordinate
  preventive and breakdown maintenance
  of equipment with Engineering and Maintenance.
• Participate in
  CAPEX and OPEX planning
  for the department.
• Initiate, coordinate and verify
  CAPA actions
  arising from internal or external audit observations.
• Guide team members in maintaining
  risk and hazard assessments, aspect/impact registers
  , and ensure adequacy of control measures.
• Follow and promote
  EHS procedures
  , ensuring full implementation of the EHS management system; review progress of EHS objectives periodically.
• Assign and monitor
  performance objectives
  for production personnel to ensure optimal manpower utilization.
• Support
  training and competency evaluation
  of production personnel to minimize manual or procedural errors.
• Ensure smooth execution of
  commercial, clinical, and developmental campaigns
  in compliance with Quality and Safety standards.
• Drive
  continuous improvement
  initiatives within team functions, skills, and employee engagement.
• Support
  process lifecycle management
  through validation cycles and ongoing improvements for consistent process robustness.
• Take active part in
  Downstream Purification (DSP-1, DSP-2)
  and
  Buffer Preparation Area
  operations as required.
• Ensure
  adequate personnel availability
  and scheduling for all planned activities.
• Ensure
  On-Time-In-Full (OTIF)
  execution of all downstream and buffer preparation activities per production plan.
• Develop
  basic SAP operation capability
  and ensure accurate entries for production activities.

Requirements

• Bachelor's Degree in
  Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry
  or equivalent field.
• 2 - 4 years of hands-on experience
  in biopharmaceutical or pharmaceutical
  Drug Substance manufacturing
  or related process operations (Downstream, Upstream, or Buffer Preparation).
• Strong understanding of
  GMP, process operations, and cleanroom practices
  .
• Prior exposure to
  audits, deviations, CAPA handling, and EHS systems
  preferred.
• Working knowledge of
  process equipment
  (tanks, filtration skids, chromatography, UF/DF systems).
• Familiarity with
  batch records, electronic documentation, and SAP transactions
  .
• Excellent understanding of
  Good Documentation Practices (GDP)
  and
  ALCOA+ principles
  .

About The Benefits

At Biocon, you'll receive a competitive salary and a robust benefits package—medical, dental, and insurance coverage that extends to you and your family. Enjoy annual and casual leave, complimentary duty meals, access to an in-house gym/sports room, and exceptional opportunities for career advancement.