Director, Process Chemistry
About The Position
The Director of Process Chemistry is an experienced process chemist with a proven track record of successful process development, project leadership and oversight of manufacturing of small-molecule drug substances. You will be responsible for process research, process development and optimization, execution of technical transfers and oversight of manufacturing activities at external partners, up to and including process validation. This includes document review, QA support, and regulatory writing in support of CMC portions of clinical/commercial submissions including INDs, IMPDs, NDAs, etc.
Requirements
- Ph.D. in Organic Chemistry, or related discipline with a minimum of 12+ years of experience, or Master with a minimum of 15+ years of experience, in a CMC development organization.
- Demonstrated successful leadership in a pharmaceutical CMC drug substance development role.
- Broad experience working with and managing external CDMO partners, including use of performance and quality metrics and MSA negotiation.
- Expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation.
- Experience authoring and reviewing technical documents including, but not limited to, development reports, master batch records, analytical testing methods, and specifications.
- Deep understanding of global regulatory requirements for the manufacture, testing, and control of drug substances.
- Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and practice responding to inquiries from regulatory agency reviews.
- Strong project leadership skills with the ability to manage complex timelines, multiple stakeholders, and evolving program priorities.
- Exceptional communication and collaboration skills with a proven ability to work cross-functionally in a fast-paced, science-driven environment.
- Understanding of basic budgeting processes.
- High level of personal integrity, commitment to excellence and to our patients.
Responsibilities
- Collaborate with medicinal chemistry partners to support candidate selection and developability assessments. Advise and assist with sourcing scaffolds and intermediates as appropriate.
- Provide technical and functional project leadership on drug substance process development, manufacturing, and CDMO partner management.
- Oversee technical transfer activities between CDMOs as needed to ensure supply continuity.
- Collaborate with Analytical Development to ensure the development and validation of analytical test methods for drug substances.
- Ensure timely documentation review and approval to ensure supply continuity (Batch records, specifications, change controls, etc.).
- Provide technical input to deviation investigations to assess impact to product and manufacturing processes.
- Partner with Quality Assurance and CMC Regulatory to develop and implement appropriate processes and controls to ensure drug substance batches meet specifications and adhere to cGMP when required.
- Partner with the program teams to design API production schedules while maximizing production and cost efficiencies.
- Author and review technical documents, process development reports, and drug substance sections for IND, IMPD and global marketing applications.
- Stay current with applicable global regulations and industry standards.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
