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

Senior Officer