Associate Director, Process Chemistry

Frontier Medicines is seeking a highly motivated individual for a newly created Associate Director role in Process Chemistry in Frontier’s South San Francisco 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.
Requirements
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, 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 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 suppor
What are we looking for?
Ph.D. in organic chemistry or similar with 7-12 years or Master’s 15 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 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 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
At Frontier we strive to build a diverse and equitable workplace. The salary range for this role is $140,000 - $200,000. Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits.
This compensation and benefits information is based on Frontier’s knowledge as of the date of publication, and may be modified in the future.