Associate Director, CMC Drug Product Development

The Associate Director, CMC Drug Product Development will lead pre-formulation, formulation development, tech transfer, scale-up, and manufacturing activities at Olema’s CMOs or CDMO partners. This role provides scientific expertise in solid oral dosage formulation development, early to late-stage process development, oversight of GMP drug product manufacturing at contract development sites, authoring global regulatory filings (INDs, IMPDs, NDA, etc.) and technical oversight of preclinical & clinical formulation development efforts.

Reporting to the Senior Director, Drug Development, this position will collaborate with cross functional departments and other CMC functions in a fast-paced high growth environment team to ensure the progression of Olema's small molecules from discovery through development/commercialization.

Responsibilities

• Lead preclinical and early clinical phase formulation development efforts at the CMO and provide oversight of tech transfer to GMP vendor for scale up and clinical drug product manufacturing
• Design and provide oversight of development and characterization studies in evaluating formulation development & drug product unit process feasibility
• Work closely with CMOs to address and refine formulation and process related challenges over the entire course of the clinical drug product development
• Develop strategies and execution plans for drug product development from first time in human through development of NDA ready formulations in accordance with timelines and requirements of overall development programs
• Work closely with clinical supply team to ensure uninterrupted drug product supply for ongoing studies and to strategically risk-mitigate any supply constraints
• Work closely with project management for alignment on study timeline and corresponding drug product supply plan in terms of adequately securing GMP production slots at CDMOs
• Work closely with project management to identify critical CMC decision points, gain alignment at the Program Team (PT) level and final endorsement from the Executive Commitment (EC)
• Work closely with Olema's regulatory CMC team (or consultants) to align on filing strategies from the perspective of being able to provide drug product for studies by clearing regulatory responsibilities
• Engage in identifying high quality drug product manufacturing CMOs or CDMOs in expertise, capability and capacity for effective collaboration in developing and/or commercializing Olema's molecule
• Lead formulation and process development, technology transfer, scale-up, and clinical manufacturing activities at the CMOs or CDMOs
• Review and approve manufacturing documents, protocols and reports
• Support manufacturing and quality function in solving technical issues and addressing deviation investigations
• Support the design of experiments (DoE) studies to evaluate formulations and process parameter at CDMOs to support NDA filings
• Support the late-stage process development and optimization activities to identity CPPs, CQAs etc. leading to process performance qualification and commercialization
• Write technical reports and author CMC sections of regulatory submissions related to drug product from IND through NDA stage of development

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• Ph.D. / M.S in Pharmaceutical Science, Chemical Engineering or related field
• 8+ years' experience in pre-formulation and formulation development for small molecules, preferably solid dosage forms, 5+ years in managing outsourced development activities
• Experience in formulation and process development; preferably with direct experience with late-stage oral solid dose manufacturing process
• Good working knowledge of GMP requirements for drug product development and manufacturing
• Good understanding of ICH, FDA, EMA guidance's in CMC and Quality areas
• Effective written, oral communication and interpersonal skills
• Experience in leading formulation projects in pre-formulation, formulation development, process selection and scale up, and oversight of GMP manufacture
• Be self-motivated, organized, detail-oriented, team-oriented, & problem-solving oriented
• Being proactive, strategic & skillful in multi-tasking
• Excel in team settings with ability to think critically, outside of the box for problem-solving and to work independently
• This position may require up to 10 - 25% travel time

The base pay range for this position is expected to be $183,000 -$191,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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