Description:
The Associate Director*, Process Chemistry position is ideal for someone who thrives in a dynamic and fast-paced work environment and rises to meet challenges. Reporting to the Head of CMC, the Associate Director will oversee and manage DS GMP production activities and preparation for registration. You will work closely with contract manufacturing organizations (CMOs) on commercial and clinical manufacturing, as well as on process scale updates and related activities. In addition, you will identify, escalate, and solve any obstacles to ensure all DS production activities run smoothly and the documentation is accurate and comply with regulatory guidelines and quality standards.
- title commensurate with experience
Roles & Responsibilities
- Oversee and manage CMOs counterparts including delivering feedback and holding others to timelines and deliverables while maintaining strong professional relationships and ensuring compliance with quality standards (SOPs, GMP etc.)
- Manage tasks and deliverables towards assembling required information and contribute to respective documents (e.g. risk analysis, briefing books, IND, IMPD, study plans and reports) in close collaboration with other relevant stakeholders
- Responsible for ensuring that drug substance (DS) plan aligns with overall development program and supports future commercial demands
- Support (review and author) the company’s regulatory submissions and documentations (clinical and commercial)
- Review and approve batch records, product specifications and all other documents related to drug substance manufacturing
- Lead DS manufacturing process scale up and all related activities
- Review stability results and conduct trend analysis
- Lead qualification of secondary sources for key starting materials
Qualifications & Experience
- M.Sc . in Organic Chemistry, PhD preferred
- 7+ years’ experience in Chemical Research & Development and Commercial product manufacturing in GMP environment
- Demonstrated track record of working with CMOs in line with contractual deliverables within timelines and budgets
- Experience in multi-step chemical process development and manufacturing, including process parametrization, validation and scale-up
- Experience with regulated industry Product Development and Regulatory requirements (knowledge of FDA and EMA requirements e.g., cGMP and marketing applications, and ICH guidance affecting drug substance development (ICH Q1 to ICH Q13)
- Working and theoretical knowledge of manufacturing, processing and testing equipment
- Demonstrated experience with regulatory submissions in various markets with emphasis on marketing authorization, post-marketing and late stage development