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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.

Robust cross-functional communication.

Key Competencies

Technical expertise in pharmaceutical manufacturing.

Process troubleshooting ability.

Documentation accuracy.

Regulatory compliance awareness.

Project coordination skills.

📌 Senior Officer (Indore)
🏢 Rubicon Research
📍 Indore