Director, Process Chemistry
Our client is a biotechnology company. They have asked us to assist them in a search for a Director, Process Chemistry.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Leads and manages small molecule process research. Identifies and resolves key scale-up challenges. Optimizes synthetic processes that allows delivery of active pharmaceutical ingredients for clinical studies through commercialization in a timely and cost-effective manner.
- Is responsible for process development and implementation of control strategies.
- Designs and oversees relevant pre-NDA activities.
- Establishes a drug substance strategy and negotiates contracts with CROs and CMOs.
- Reviews and approves master batch records, validation protocols/reports and specifications required for drug substance manufacturing.
- Works with quality assurance to manage the release of GMP drug substance and resolve technical issues or deviations.
- Supports cross functional project teams. Understands and supports the needs and requirements from other functional groups.
- Oversees and reviews Drug Substance CMC sections for regulatory submissions.
- Prepares RFPs, SOW documents, and vendor specifications documents as required.
- Participates in budget planning and forecasting for API expenditures.
- Identifies execution risks and develop contingency plans as needed.
- A PhD in Organic Chemistry or Chemical Engineering or other relevant field with significant experience in industry is required.
- Must have at least 10 combined years of experience in Process Chemistry, cGMP Manufacturing, Contract Manufacturing or Quality.
- Direct experience in small molecule API/Drug Substance manufacturing supporting both clinical and commercial products is required.
- Must have experience working with International Contract Manufacturing Organizations.
- Experience with preparing regulatory submissions at all product development stages through commercialization is required.
- Must have experience in a fast-paced entrepreneurial environment.
- The ability to travel, both domestically and internationally is required.
- Must have excellent verbal and written communication skills.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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