
Senior Formulation Development Specialist
6 days ago
About this Key Role:
We are seeking a highly experienced Formulation Development Manager with technical expertise in optimizing manufacturing processes.
Main Responsibilities:
- Process Optimization: Design and optimize manufacturing processes to ensure timely delivery of products in regulated markets.
- Manufacturing Process Evaluation: Assess manufacturing processes using statistical methods like DoE and QbD to define design space, control strategy, critical parameters, and identify process risks.
- Site Selection: Evaluate manufacturing sites based on formulation and process complexity/feasibility.
- Technology Transfer: Lead technology transfer function with project management skills to ensure successful scale-up of new products and effective launches.
- Product Transfers: Define procedures for seamless product transfers between development and manufacturing, ensuring robust scale-up, accurate filings, and successful launches.
- Subject Matter Expertise: Serve as SME for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations.
- Standards Implementation: Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities.
- Project Initiation: Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
- SOP Review: Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines.
Required Skills and Qualifications:
- 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.
About Our Organization:
We are a leading pharmaceutical company committed to delivering high-quality products and services.
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