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Senior Pharmaceutical Process Engineer
2 weeks ago
Experience: 12 to 16 Years of progressive experience in formulation development, process optimization, and technology transfer. Qualification: M Pharm.
Responsibilities:- Design, optimize, and troubleshoot manufacturing processes for regulated markets (US, Canada, EU) within allotted timelines.
- Evaluate manufacturing processes using DOE and QbD to define design space, control strategy, critical/key parameters, and identify process risks.
- Screen manufacturing sites based on formulation and process complexity/feasibility.
- Lead Technology Transfer function with project management skills to ensure successful scale-up of new products and effective launches.
- Define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
- Serve as SME for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
- Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities.
- Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
- Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines, technical changes, change control, deviations, and relevant documents.
- Expertise in formulation development of various dosage forms with strong knowledge of process optimization.
- Hands-on experience in technology transfer and scale-up.
- Strong understanding of regulatory guidelines such as USFDA, EMA, WHO.
- Excellent documentation, communication, and analytical skills.
- Ability to work in a fast-paced, dynamic environment.
- Project management and cross-functional coordination.
