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Senior Director Process Development
4 months ago
Senior Director of Process Development:
Meet has partnered with a Cambridge biotech leading in cell therapy treatments in the ophthalmology space. Our client recently received regulatory approval for one of their products overseas and is looking to replicate this in the US. They are seeking a tenured Senior Director of Process Development to join their growing team and support the development of their assets. This role is onsite at their Cambridge location, and our client offers a competitive relocation package to those interested
**Key Responsibilities:**
- Design and execute detailed experiments to comprehend Drug Substance and Drug Product processes, establishing robust, integrated process control strategies.
- Conduct gap analyses and risk assessments to pinpoint issues and deficiencies, providing recommendations for studies and solutions aligned with manufacturing processes and regulatory/commercial requirements.
- Develop and implement strategies for Process Performance Qualification (PPQ) and post-approval process enhancements, ensuring a balanced approach to quality, financial, and inventory risks.
- Support regulatory strategies and activities, including authorship and review of CMC documentation for regulatory submissions.
- Assist in the development of standard operating procedures, FMEA, batch records, and analytical sampling plans.
**Qualifications and Education:**
- PhD in life sciences or engineering, with over 10 years of pertinent industry experience.
- Robust cell therapy experience required - preferably Allogenic and late stage.
- Proven leadership in managing diverse technical teams and interacting effectively with external manufacturing partners and academic collaborators.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation among diverse stakeholders.
