Formulation Development and Process Optimization Lead
7 days ago
Job Title: Formulation Development and Process Optimization Lead
This is an exceptional opportunity to lead the formulation development and process optimization function, driving technical improvements for regulated markets.
Key Responsibilities:
- Develop and implement strategies for design and optimization of manufacturing processes, ensuring compliance with regulatory requirements.
- Evaluate manufacturing processes using Design of Experiments (DoE) and Quality by Design (QbD) principles to define design space, control strategy, critical/key parameters, and identify process risks.
- Screen manufacturing sites based on formulation and process complexity/feasibility, ensuring seamless product transfers between development and manufacturing.
- Lead Technology transfer function with project management skills to ensure successful scale-up of new products and effective launches.
- Serve as Subject Matter Expert (SME) for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations.
- Define and implement standards for formulation technology transfer, being 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 Standard Operating Procedures (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.
This role offers an exciting opportunity to work with a talented team, driving innovation and excellence in pharmaceutical formulations. If you are a motivated professional with a passion for process optimization and leadership, we encourage you to apply for this challenging and rewarding position.
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