Role & responsibilities

Product Development & Technology Transfer :

- Lead formulation and process development activities for sterile injectable products.
- Plan and execute scale-up and exhibit batches.
- Coordinate technology transfer from R&D; to manufacturing sites.
- Prepare process validation and technology transfer documents.

MSAT Support :

- Provide scientific and technical support to commercial manufacturing.
- Investigate process deviations, OOS/OOT results, and market complaints.
- Recommend CAPA and process improvement initiatives.
- Monitor process performance and product quality trends.

Process Optimization

- Identify opportunities for yield improvement, cycle time reduction, and cost optimization.
- Perform risk assessments and statistical analysis.
- Drive continuous improvement projects.
- Regulatory & Compliance

- Support preparation of dossiers, regulatory responses, and deficiency replies.
- Ensure compliance with cGMP, Data Integrity, and regulatory requirements.
- Participate in audits conducted by USFDA, MHRA, EMA, WHO,



and other agencies.

Team Management

- Lead and mentor a team of scientists/executives.
- Plan resource allocation and project timelines.
- Drive performance, capability development, and succession planning.

Preferred candidate profile

Educational Qualification:

- M. Pharm (Pharmaceutics) Preferred

Experience

- 10-15 years of experience in Injectable Formulation Development, PDL, MSAT, or Technology Transfer.

Technical Skills

- Injectable formulation development
- Sterile manufacturing processes
- Process validation
- Technology transfer
- Scale-up studies
- QbD principles
- Risk assessment tools (FMEA)
- Statistical data analysis
- Regulatory filing support

Behavioral Competencies

- Leadership & Team Management
- Problem Solving
- Decision Making
- Stakeholder Management
- Communication Skills
- Innovation & Continuous Improvement

📌 PDL/MSAT (Injectable)- Manger (Ahmedabad)
🏢 Intas
📍 Ahmedabad