Senior Director CMC Operations

89Bio, Inc. San Francisco , CA 94118

Posted 2 months ago

THE COMPANY
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. 89bio's lead product candidate, BIO89-100, is being developed for the treatment of nonalcoholic steatohepatitis, or NASH. 89bio also intends to develop BIO89-100 for the treatment of severe hypertriglyceridemia. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or nonalcoholic fatty liver disease and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. The Company recently closed its upsized initial public raising a gross $97.6 million.

Headquartered in San Francisco, the Company also has a small R&D and operations team in Herzliya, Israel.

THE ROLE

Reporting to the CTO, the Senior Director CMC Operations will lead a team to execute the CMC Operations strategic plan to create value by advancing clinical programs to meet 89bio's goals and objectives. The position will oversee/manage all activities related to Process Development, Analytical Development, Manufacturing, Quality Control (QC), and Supply Chain (SC). Managing complex and intertwined scientific/technical and operational logistical CMC related activities, the position will support the Company's drug development activities from preclinical through clinical and commercial at external Contract Manufacturing Organization (CMO) and Contract Testing Labs (CTL.) The position will also partner with the CTO in developing Technical Operations strategic plan. The position may be based globally with up to 25% travel.

Principal Duties and Responsibilities

  • Build and develop a global CMC Operations team/organization including establishing SOP's and other foundational processes

  • Manage multiple global CMOs and CTLs for process optimization, cGMP manufacture, supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs and commercial launch

  • Work with Regulatory and Quality teams to manage drug candidate development

  • Project API and DP needs for preclinical and clinical programs (with the clinical team), and associated budgets (with finance team)

  • Develop and implement strategy and DOE (design of experimentation) for optimizing and controlling quality of API and DP

  • Write and review documents for INDs / regulatory submissions; represent the company as the CMC expert before U.S. and other regulatory authorities

  • Deliver robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile

  • Manage supply chain and logistics in support of clinical studies and commercial launch

  • In coordination with Quality Assurance, execute plans for overall compliance; validation and registration of API and DP as required by cGMP, ICH, FDA, and other regulations

  • Manage timelines and budget for all CMC related projects

  • 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

REQUIRED EDUCATION, SKILLS & EXPERIENCE

  • BS., M.S., or equivalent experience in biology, biochemistry, chemical engineering, or related field

  • 7-10+ years of industry experience in CMC operations/drug development

  • 5+ years of management experience and in-depth knowledge/experience leading/developing professionals

  • Start-up/early-stage development through commercialization preferred

  • Knowledgeable of various manufacturing platforms (small molecule, cell therapy, antibodies, etc.) is a plus

  • Experience with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA, EMEA and other regulations

  • Familiarity with managing stability programs is a plus

  • Experience selecting and managing US and International external vendors (CMOs, CTLs, etc.)

  • Considerable experience/mastery of Project/Program Management (PM) related to drug development

  • Demonstrated history of simultaneously managing multiple projects; success working in a dynamic, fast-paced, timeline-based environment with short lead times

  • 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 stakeholders

  • Strong regard as team player with a 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

Job Details

Reference # 13240 Posted on 03 Sep 2019 Closes on 01 Mar 2020 12:43 Property name 89bio Inc Location(s) San Francisco, CA Department Career level Hours/Status More details (document)


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Senior Director CMC Operations

89Bio, Inc.