Assistant Manager

Job Description:

Responsibilities

• Technology Transfer Leadership
•  Lead end-to-end technology transfer of formulations (OSD / semi-solids as applicable).
•  Plan, review, and approve Technology Transfer Protocols (TTP), Reports (TTR), and risk assessments.
•  Coordinate transfers from R&D, pilot plant, contract manufacturers, or global sites.
•  Ensure readiness of manufacturing processes, equipment, and documentation.
• Process Scale-Up & Validation
•  Lead scale-up, exhibit, and PPQ batches.
•  Define and monitor CPPs, CQAs, and control strategies.
•  Support and review process validation, cleaning validation, and hold time studies.
•  Drive process optimization and yield improvement initiatives.
• Cross-Functional Coordination
•  Act as a technical interface between R&D, Production, QA, QC, Engineering, Supply Chain, and Regulatory Affairs.
•  Provide technical inputs for regulatory filings, queries, and variations.
•  Support new product introduction (NPI) and site transfer projects.
• Compliance & Regulatory
•  Ensure all activities comply with cGMP, ICH, USFDA, EMA, WHO, and other applicable guidelines.
•  Lead and support regulatory inspections, customer audits, and internal audits related to tech transfer.
•  Handle deviations, change controls, CAPA, and risk management for transferred products.

Qualification & Experience

• Education: B. Pharm / M. Pharm
•  Strong expertise in pharma formulation processes and scale-up.
•  Hands-on experience with process validation and regulatory batches.
•  Sound knowledge of QbD, risk assessment tools (FMEA, Ishikawa).
•  Experience handling regulated markets (US/EU).