Assistant Manager
Job Description
Purpose
To lead and manage technology transfer activities for pharmaceutical formulations from R&D or external sources to commercial manufacturing sites, ensuring robust, compliant, and efficient production across scales.
Position / Job Title
Assistant Manager Technology transfer
Department
Technology Transfer
Reporting To
Asst. General Manager/General Manager
Location
Indore
Years of Experience
6–10 years of experience in Technology Transfer, Formulation Development, or Technical Operations within a pharmaceutical formulation company.
Dosage Form
Solid & Semi solid
Job Responsibilities / Deliverables
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.
Team & Knowledge Management
• Guide, review, and mentor Executives / Officers in the technology transfer team.
• Review technical documentation including MFR/BMR, SOPs, PFDs, and control strategies.
• Promote QbD principles, data integrity, and continuous improvement.
Qualifications
Education: B. Pharm / M. Pharm
Additional notes
Technical Skills & Knowledge
• 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).
Behavioral & Leadership Skills
• Project management and planning ability
• Strong communication and stakeholder management
• Decision-making and problem-solving skills
• Team leadership and mentoring capability
Preferred / Added Advantages
• Experience in site transfer or CMO technology transfer
• Exposure to global regulatory submissions
• Certification in Lean / Six Sigma / Project Management