Director/Sr. Director, Head of Process Chemistry

Frontier Medicines is seeking a highly motivated individual for a newly created Director/Senior Director role in Process Chemistry in either Frontier’s South San Francisco or Boston office. The successful candidate will lead internal and external resources to develop scalable manufacturing processes for Frontier’s small molecule pipeline. The role will include oversight of CDMOs from process chemistry development through to drug substance manufacturing.

What will you be doing?

• Responsible for leading all small molecule drug substance development and manufacturing
• Management of drug substance process chemistry development, scale up, and manufacturing for GLP studies and GMP manufacturing at CDMOs
• Develop manufacturing processes that are scalable, safe, cost-effective, and environmentally friendly
• Responsible for CRO/CDMOs, including selection, maintaining strong relationships, technology transfer, and cGMP API manufacturing
• Leverage external expert consultants in the field of drug substance to assist achieving goals
• Work with CROs to utilize state-of-the-art practices to address challenges involving salt, polymorph and particle size attributes, synthesis, reaction kinetics, process safety and impurity profile management
• Partner with Medicinal Chemistry on scale-up synthesis to facilitate candidate nomination
• Apply discipline excellence to solve synthesis, process design, production equipment, and scale-up challenges
• In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to support all development candidates
• ·Work collaboratively with Quality Assurance and Regulatory to review analytical documents, stability results, manufacturing batch records and regulatory documents pertaining to drug substance and approve as required
• Assist with authoring related process development reports and regulatory sections
• Interact with cross functional teams to provide CMC technical information, guidance, and support

What are we looking for?

• Ph.D. in organic chemistry with at least 10+ experience in small molecule drug development and manufacturing in biotech and/or pharma industry or
• Masters degree with 15+ years relevant experience in a biotech or pharma setting
• Extensive experience with process chemistry development, scale-up, tech transfer, drug substance characterization and working with CDMOs
• Experience in cGMP manufacturing, leveraging, and managing CRO/CDMOs for the manufacture of regulatory starting materials and drug substances.
• Experience overseeing related areas for regulatory submissions and knowledge of current regulations.
• Experience with quality by design (QbD), process validations and statistical design of experiments (DOE) is preferred
• Experience with early through late-stage process development is strongly preferred
• Team player who will be able to collaborate effectively in a cross-functional matrix team environment including DMPK/Nonclinical groups for safety assessment
• Exceptional oral communication and writing skills
• A thorough understanding of ICH guidelines, GMP/GLP manufacturing, and related regulatory requirements is required
• Ability to travel domestically and/or internationally to achieve goals, when required