Executive

Purpose

To support and execute technology transfer activities for pharmaceutical formulations from R&D to manufacturing sites or

between two manufacturing sites, ensuring robust, compliant, and reproducible commercial production.

Position / Job Title

Executive Technology transfer

Department

Technology Transfer

Reporting To

Asst. General Manager/General Manager

Location

Indore

Years Of Experience

Minimum of 3-5 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 Activities

Execute technology transfer of oral solid or semi-solid formulations from R&D / pilot scale /commercial scale at one manufacturing unit to another commercial manufacturing unit

Prepare, review, and execute Technology Transfer Protocols (TTP) and Technology Transfer Reports (TTR).

Coordinate with R&D, Production, QA, QC, Regulatory Affairs, and Engineering during transfer activities.

Support scale-up and scale-down studies and process optimization.

Manufacturing & Process Support

Assist in process validation, including PPQ batches and commercial batch execution.

Troubleshoot manufacturing issues during trial, exhibit, and validation batches.

Ensure correct transfer of critical process parameters (CPPs) and critical quality attributes (CQAs).

Support equipment qualification and process capability studies.

Documentation & Compliance

Prepare and review manufacturing instructions, BMR/BPR, SOPs, and process flow diagrams.

Ensure compliance with cGMP, ICH, USFDA, EMA, WHO, and other regulatory guidelines.

Participate in regulatory audits and inspections related to technology transfer activities.

Cross-Functional Coordination

Act as a technical liaison between R&D and manufacturing teams.

Support regulatory submissions by providing technical data and responses.

Collaborate with supply chain and procurement for raw material and process readiness.

Qualifications

B. Pharm / M. Pharm

Additional Notes Technical Skills & Knowledge

Strong understanding of pharmaceutical formulation processes (OSD preferred).

Knowledge of scale-up principles, validation, and GMP documentation.

Familiarity with regulatory expectations for tech transfer.

Basic understanding of QbD, risk assessment (FMEA) is an advantage.

Behavioural & Soft Skills

Good communication and coordination skills

Strong documentation and analytical abilities

Problem-solving mindset

Ability to work in cross-functional teams

Preferred Skills (Optional)

Experience with regulated markets (US/EU)

Exposure to new product introduction (NPI)

Knowledge of Lean / Six Sigma tools