Director/Sr. Director, Head of Process Chemistry (San Francisco)

Frontier Medicines is seeking a highly motivated individual for a newly created Director/Senior 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.RequirementsWhat will you be doing?Responsible for leading all small molecule drug substance development and manufacturingManagement of drug substance process chemistry development, scale up, and manufacturing for GLP studies and GMP manufacturing at CDMOsDevelop manufacturing processes that are scalable, safe, cost-effective, and environmentally friendlyResponsible for CRO/CDMOs, including selection, maintaining strong relationships, technology transfer, and cGMP API manufacturingLeverage external expert consultants in the field of drug substance to assist achieving goalsWork 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 managementPartner with Medicinal Chemistry on scale-up synthesis to facilitate candidate nominationApply discipline excellence to solve synthesis, process design, production equipment, and scale-up challengesIn 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 requiredAssist with authoring related process development reports and regulatory sectionsInteract with cross functional teams to provide CMC technical information, guidance, and supportWhat 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 orMasters degree with 15+ years relevant experience in a biotech or pharma settingExtensive experience with process chemistry development, scale-up, tech transfer, drug substance characterization and working with CDMOsExperience 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 preferredExperience with early through late-stage process development is strongly preferredTeam player who will be able to collaborate effectively in a cross-functional matrix team environment including DMPK/Nonclinical groups for safety assessmentExceptional oral communication and writing skillsA thorough understanding of ICH guidelines, GMP/GLP manufacturing, and related regulatory requirements is requiredAbility to travel domestically and/or internationally to achieve goals, when requiredBenefitsHealth 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 DisabilityTraining & DevelopmentFree Food & SnacksWellness ResourcesStock Option PlanAt Frontier we strive to build a diverse and equitable workplace. The salary range for this role is $205,000 - $275,000. 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.