Manager Analytical Development

Role Summary:

Analytical Development Manager

Key Responsibilities:

• Develop and validate analytical methods for assay, dissolution, related substances, and other QC parameters.
• Conduct analytical testing to support 

  formulation development

  , 

  stability studies

  , and 

  regulatory submissions

  .
• Ensure data integrity, GMP compliance, and adherence to ICH, USP/Ph. Eur. guidelines.
• Collaborate with Formulation, QA, RA, and external manufacturing/testing partners.
• Prepare and review analytical protocols, reports, specifications, and method transfer documents.
• Assist in 

  method transfer and analytical troubleshooting

   at CMOs or partner labs.
• Maintain and calibrate analytical instruments (HPLC, GC, UV, IR, etc.)

Required Qualifications:

• M.Pharm / M.Sc in Pharmaceutical Chemistry, Analytical Chemistry, or related field.

• 3–7 years

   of hands-on experience in 

  analytical method development and validation

   for small molecule generic drugs.
• Familiarity with 

  ICH guidelines

  , regulatory documentation, and stability protocols.
• Experience working with common lab instruments like 

  HPLC

  , 

  GC

  , 

  Dissolution testers

  , etc.
• Strong technical documentation and analytical reasoning skills.

Preferred Experience:

• Exposure to 

  regulated market

   requirements (USFDA, EMA).
• Experience in handling OOS/OOT investigations and change controls.
• Prior experience with 

  technology transfer

   or 

  working with CMOs

   is a plus.