Job Description & How to Apply Below
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
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