Associate Director, Process Chemistry
South San Francisco, California, United States On-site
$200,000–$220,000 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
We are seeking an experienced and highly motivated Associate Director of Process Chemistry to manage and drive drug substance process development and delivery activities across our small molecule drug discovery and development programs. This individual will fill a critical role as a subject matter expert (SME) and will contribute to the strategic direction, technical management, and operational execution for CMC development and manufacturing activities. This position is instrumental in collaborating with and managing a network of consultants and Contract Development and Manufacturing Organization (CDMO) partners to enable our efforts to discover and develop small molecule therapeutics from preclinical through commercial. We are seeking an experienced and highly motivated Associate Director of Process Chemistry to manage and drive drug substance process development and delivery activities across our small molecule drug discovery and development programs. This position is instrumental in collaborating with and managing a network of consultants and Contract Development and Manufacturing Organization (CDMO) partners to enable our efforts to discover and develop small molecule therapeutics from preclinical through commercial.
What you'll bring
- A PhD, MS, or BS degree in organic chemistry or related field with a minimum of 7 years, 10 years, or 12 years, respectively, of relevant industry experience in small molecule drug substance development with demonstrated increasing responsibilities within process chemistry.
- Exhibited track record of success in delivering timely execution of drug substance activities ranging from non-GLP and IND-enabling material supplies, through GMP clinical trial supplies and commercialization.
- Demonstrated expertise in small molecule synthetic route evaluation, process development, scale-up and manufacturing, and phase-appropriate control strategy and specification development.
- Experience with analytical techniques to support small molecule process development, with proficiency in UPLC/HPLC, GC, MS, NMR, and solid-state characterization techniques such as particle size distribution and XRPD.
- Strong understanding of Quality systems including SOPs, manufacturing record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management.
- Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph.
- Eur, BP, and JP compendia.
- Proven ability to manage and collaborate with external partners, including consultants and CDMOs.
- Excellent interpersonal and communication skills (written and oral) with the ability to effectively prepare high-quality technical documentation and concisely present data to peers, management, and external groups.
- Exhibited strong organizational and critical thinking skills with an attention to detail and data integrity enabling sound, technically driven decision making.
- Able to travel domestically and internationally as needed, up to 20% of the time.
- Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training.