CMC Operations (Small Molecule), Director/Senior Director

Company: snaphire
Location: San Francisco
Posted on: March 21, 2023

Job Description:

CMC Operations (Small Molecule), Director/Senior DirectorTHE COMPANY89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Rehovot, Israel.THE ROLEReporting to the Ex. Dir CMC operations, the Director/ Sr. Director CMC Operations (Small Molecule) will be responsible for managing activities related to scientific and technical oversight of synthetic manufacturing processes. Managing complex scientific/technical and operational logistical CMC related activities, the position will support the Company's drug development and manufacturing activities from preclinical through clinical and commercial at external Contract Manufacturing Organization (CMO) and Contract Testing Labs (CTL.)THE RESPONSIBILITIES

• Manage multiple global CMOs and CTLs for process optimization, cGMP manufacture and supply of Drug Substance (API) intermediates in support of ongoing clinical programs and commercial launch.
• Work with Regulatory and Quality teams to manage drug intermediate development.
• Function as hands-on CMC Program Lead and key point of contact to Small Molecule External CMO's to manage process development and manufacturing of intermediates for ongoing and new programs in development.
• Oversee site selection, tech-transfer, scale-up, and ongoing manufacturing at CMO's .
• Write and review documents for INDs / regulatory submissions; represent the company as the CMC expert before U.S, EU and other regulatory authorities.
• Review and approve executed/master batch records, validation protocols/reports and specifications required for drug substance manufacturing.
• In coordination with Quality Assurance, execute plans for overall compliance; validation of manufacturing process supporting API as required by cGMP, ICH, FDA, and other regulations.
• Travel as needed to CMO sites to ensure process implementation and compliance.
• Participate in authoring and updating product specifications and ensure that testing programs are in place across the vendor network to support release, stability, shelf-life extensions, and product safety.
• Partner with QA for timely release of product.
• Lead process validation activities at CMO's at the appropriate phase of development and review/approve draft protocol designs for execution.THE QUALIFICATIONS
  • B.S., M.S., or equivalent experience in in Chemistry, Organic Chemistry, chemical engineering, Biochemistry or related field.
  • 10+ years of industry experience in CMC operations / drug development.
  • Past experience managing and developing people.
  • Start-up/early to late stage development through commercialization preferred.
  • Knowledgeable of various manufacturing platforms (small molecule, proteins, pegylation etc.) is a plus.
  • Experience in deviations, change controls and OOS investigations with CMOs.
  • Experience with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA, EMEA and other regulations.
  • Experience selecting and managing US and International external vendors (CMOs, CTLs, etc.)
  • Experience with Technology transfers with CMOs.
  • Considerable experience working with Project/Program Management (PM) related to drug development and manufacturing.
  • Demonstrated history of simultaneously managing multiple projects; success working in a dynamic, fast-paced, timeline-based environment with short lead times.
  • Strong people managing skills with ability to assert and influence CMOs and achieve goals.
  • Demonstrated strategic thinking to assess and improve processes to meet global business needs.
  • Superior problem-solving skills: diagnosing complex issues; developing & implementing solutions by collaborating with the appropriate internal and external stake holders.
  • Strong regard as team player with history of collaborations/influence up, down and across teams/organization.
  • Excellent written and verbal communication skills including succinctly translating complex/technical information to/for a variety of audiences.SALARY89bio considers a range of factors when determining compensation. These considerations mean actual compensation will vary. The range for this position is $200,000 - $250,000 and will commensurate with experience.THE PERKS
    • Competitive health insurance coverage
    • Employee Stock Purchase Plan (ESPP)
    • Women's forum / mentoring
    • Office based in the heart of San Francisco, near plenty of shops and restaurants
    • Fun opportunities to engage with co-workers in-person and remotelyAll qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability. Proof of COVID vaccination is a condition of employment

Keywords: snaphire, San Francisco , CMC Operations (Small Molecule), Director/Senior Director, Executive , San Francisco, California