Formulation R&D (Sr Manager/AGM)

Formulation R&D professional

regulatory and GMP

Key Responsibilities:

• Lead

  formulation and process development

  for oral dosage formssoft gelatin capsules, tablets, and sachets.
• Plan, design, and execute

  lab-scale and pilot-scale trials

  to optimize formulations.
• Troubleshoot and resolve

  formulation or process-related challenges

  .
• Drive

  technical innovation

  in formulation design and process improvement.
• Develop and evaluate

  stability studies

  to finalize product composition.
• Oversee preparation of

  technical documentation, reports, and batch manufacturing records

  .
• Support

  technology transfer

  activities from R&D to manufacturing (scale-up and validation).
• Ensure compliance with

  GMP, ICH, and regulatory filing requirements

  (including ANDA submissions for regulated markets).
• Coordinate with internal and external stakeholders to ensure

  timely execution of R&D projects

  .
• Provide

  technical mentoring and leadership

  to the formulation development team.

Key Requirements:

• Education:

  B.Pharm / M.Pharm (Pharmaceutical Sciences or related field).

• Experience:

  Minimum

  15 years

  in the pharmaceutical industry, preferably in

  Formulation R&D

  .
• Proven experience in

  soft gelatin capsule and tablet formulation development

  .
• Hands-on exposure to

  ANDA filings and regulatory submissions

  for regulated markets.
• Strong knowledge of

  GMP guidelines, formulation design, analytical methods, and scale-up processes

  .
• Excellent

  problem-solving, leadership, communication, and people management

  skills.
• Ability to work on multiple projects with cross-functional teams.