Associate Director/Director, Drug Substance Development

Frontier Medicines is seeking a highly motivated individual for a position of Associate Director/Director, Drug Substance Development in Frontier’s South San Francisco office. The successful candidate will lead internal and external resources to develop scalable drug substance manufacturing processes for Frontier’s small molecule pipeline. The role will include oversight of CDMOs from process chemistry development through to drug substance manufacturing. The ideal candidate possesses strong understanding of organic chemistry and its application in drug substance process development.

Requirements

What will you be doing?

• Responsible for strategy and management of all small molecule drug substance chemistry and process development, technology transfer, scale up and manufacturing activities

• Timely management of drug substance manufacturing for GLP studies and GMP manufacturing at CDMOs
• Develop manufacturing processes that are scalable, safe, cost-effective, and environmentally friendly
• Responsible for CROs/CDMOs, including selection, technology transfer, and cGMP API manufacturing
• Leverage external expert consultants in the field of drug substance development 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 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 Head of CMC, 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 Quality Assurance with SOP development and investigations
• Assist with authoring related process development protocols, reports and regulatory sections
• Interact with cross functional teams to provide CMC technical information, guidance, and support
• Represent the company as the drug substance subject matter expert in discussions with the regulatory agencies

What are we looking for?

• Ph.D. in organic chemistry or similar with 8 – 12 years’ experience or MS with 12 – 15 years’ experience in small molecule drug development and/or manufacturing in 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 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 validation and statistical design of experiments (DOE) is preferred
• Experience with early through late-stage chemical process development, optimization and scale up is strongly preferred
• Team player who will be able to collaborate effectively in a cross-functional matrix team environment including Safety Assessment and DMPK groups
• Exceptional oral communication and writing skills
• A thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required
• Ability to travel domestically and/or internationally to achieve goals, when required

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Training & Development
• Free Food & Snacks
• Wellness Resources
• Stock Option Plan