Purpose
This role is responsible for coordinating and executing the transfer of pharmaceutical formulations, processes, and analytical methods from R&D or external sites to manufacturing plants. The role ensures smooth scale-up, regulatory compliance, and successful commercial production while maintaining product quality and process consistency.
Position / Job Title
Senior officer - Technology transfer
Department
Technology Transfer
Reporting To
Asst. General Manager/General Manager
Location
Indore
Years Of Experience
Minimum of 2-5 years of experience in Technology Transfer, Formulation Development, or Manufacturing Operations in a pharmaceutical formulation company.
Dosage Form
Solid & Semi solid
Job Responsibilities / Deliverables
- Technology Transfer Execution
Execute technology transfer of pharmaceutical formulations from R&D to manufacturing.
Review and understand product development reports, master formula, and process parameters.
Prepare and review Technology Transfer Protocols and Reports.
Coordinate trial, exhibit, validation, and commercial batches.
- Process Scale-Up & Optimization
Support scale-up activities from lab scale to pilot and commercial scale.
Monitor critical process parameters (CPP) and critical quality attributes (CQA).
Identify process improvements for robust manufacturing.
- Documentation & Compliance
Prepare And Review Key Documents Such As
Technology Transfer Protocol (TTP)
Technology Transfer Report (TTR)
Batch Manufacturing Record (BMR)
Process Validation Protocols
Risk assessment documents
Ensure compliance with GMP, regulatory guidelines, and internal SOPs.
- Cross-Functional Coordination
Coordinate With Departments Such As
R&D
Production
Quality Assurance (QA)
Quality Control (QC)
Regulatory Affairs
Engineering
Support troubleshooting during initial manufacturing batches.
- Process Validation & Commercialization
Participate in process validation activities.
Monitor initial commercial batches to ensure product quality.
Review deviations, change controls, and CAPA related to technology transfer.
- Regulatory & Audit Support
Provide technical support during regulatory inspections and audits.
Ensure transferred processes meet global regulatory requirements (USFDA, EU, WHO, MHRA etc.).
Qualifications Education
B. Pharm / M. Pharm
Additional Notes Required Skills
Knowledge of pharmaceutical formulation processes (tablets, capsules, injectables, orals, etc.)
Understanding of process validation and scale-up
Strong knowledge of GMP guidelines
Experience in technical documentation
Good problem-solving and analytical skills
Strong cross-functional communication
Key Competencies
Technical expertise in pharmaceutical manufacturing
Process troubleshooting ability
Documentation accuracy
Regulatory compliance awareness
Project coordination skills
