Formulation Development Manager

Role Summary:

Formulation Development Manager

Key Responsibilities:

• Lead and manage end-to-end 

  formulation development

   of generic drug products (solid orals, liquids, injectables).
• Design and execute 

  pre-formulation

  , 

  compatibility studies

  , and 

  QbD-based

   formulation strategies.
• Oversee 

  scale-up

   and 

  tech transfer

   activities to in-house or third-party manufacturing sites/CMOs.
• Collaborate with cross-functional teams including Analytical, Regulatory, Quality, and Manufacturing.
• Prepare and review development reports, batch records, and technology transfer documentation.
• Support regulatory filings (ANDA, CTD modules) with formulation data and justifications.
• Troubleshoot formulation or scale-up challenges post-transfer at commercial sites.

Required Qualifications:

• M.Pharm / M.S. (Pharm) in Pharmaceutics or equivalent.

• 5–10 years

   of experience in 

  formulation development

   of small molecule generics.
• Proven experience with 

  tech transfer and scale-up

  , especially in 

  CMO environments

  .
• Hands-on knowledge of formulation equipment, GMP practices, and ICH guidelines.
• Strong documentation, analytical thinking, and problem-solving skills.

Preferred Experience:

• Exposure to regulated markets (e.g., US/EU).
• Familiarity with BA/BE studies and clinical batch requirements.
• Experience in lifecycle management, reformulation, or complex generics is a plus.