Senior Officer
Job Description
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
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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