CMC Operations (Drug Substance), Head of/Senior Director

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.

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).

THE ROLE

Reporting to the Vice President, CMC Operations, the Head of / Senior Director CMC Operations (Drug Substance) will manage activities related to Process Development, Tech Transfer and Manufacturing of Drug substance.

Managing complex and intertwined scientific / technical and operational logistical CMC related activities, the position will support the Company’s drug development and manufacturing activities for phase 3 and commercialization at external Contract Development and Manufacturing Organization (CDMO) and Contract Testing Labs (CTL).

THE RESPONSIBILITIES

• Act as the technical lead for all DS matters including DS, T2 and ST6, be responsible for resolving technical issues related to process transfer, process scale-up, COGs reduction and commercialization.
• Act as the in-house validation expert and be responsible for CMC process validation including risk assessment, IPC, process characterization and validation following QbD guideline, as well as successful execution of PPQs and PAI to support BLA / MAA approval.
• Manage multiple global CDMOs for tech transfer, process optimization, process scale-up and cGMP manufacturing and testing to ensure IP supply for ongoing clinical programs and commercial launch.
• Manage CDMOs to optimize DS process to improve yield, quality and scalability, and reduce the product COG with the ultimate goal of developing a scalable, robust and cost-effective manufacturing process for commercialization.
• Manage CDMOs to get ready for commercialization for both US and EU.
• Write and / or review technical documents including development reports, tech transfer reports, manufacturing batch records, campaign summary reports, risk assessment and deviation investigation reports etc.
• Participate and present at the internal and external project meetings as technical SME.
• Participate in preparing in-process testing plan and product specifications, and ensure that test methods are in place across the vendor network to support in-process testing, lot release, stability, shelf-life extensions, and product safety.
• Partner with QA for timely lot release, stability testing, deviation / OOS investigation, change control and data trending analysis etc.
• Write and review documents for INDs / regulatory submissions as technical SME to support regulatory interactions with the FDA and other regulatory authorities.
• In coordination with QA execute plans for overall compliance; validation and registration of DS as required by cGMP, ICH, FDA, and other regulations.

THE QUALIFICATIONS

• B.S., M.S., or equivalent in biology, biochemistry, chemical engineering, biochemical engineering or related field.
• 20+ years of industry experience in CMC process development, IPC testing and manufacture.
• Solid working knowledge of various manufacturing platforms (Microbial fermentation process, IB recovery and refolding, CHO cell culture and purification, Pegylation, PEGylated protein purification etc.) is required.
• Strong scientific knowledge on process development using DoE, process scale-up, process characterization and validation is required.
• Experience selecting and managing US and International external vendors (CMOs, CTLs, etc.) is required.
• Experience in tech transfer and managing CDMOs on cGMP manufacturing, deviations, change controls and OOS investigations etc is required.
• Late stage development and commercialization experience is required.
• Experience in regulatory filings (i.e. IND, CTA, BLA etc.) is preferred.
• 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-driven 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.
• A good team player with track record 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 .

SALARY & LEVEL

89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary.

The salary range for this position is $240,000 - $265,000 and will be commensurate with experience.

THE PERKS

• Competitive health insurance coverage
• Generous PTO allowance
• 401k match
• Employee Stock Purchase Plan (ESPP)
• Commuter Benefits
• 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 remotely

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.

Proof of Covid vaccination is a condition of employment.

Notice to Recruiters : To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly.

All recruitment is managed through the 89bio Talent Acquisition Team.