Associate Director/Director, CMC Quality Assurance

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

The Associate Director / Director, Quality Assurance*, reporting into the Sr. Director, CMC Quality Assurance, is responsible for the product quality lifecycle from early phase clinical trials to commercial launch and post marketing activities and will execute a strategy for commercial readiness.

The position is responsible for ensuring product quality by performing quality system lot release and deviation management.

The successful candidate with also assist with the review of applicable Quality sections of regulatory submissions and interact closely with the CMC and clinical teams on lot supply, quality oversight, and critical issue management.

This position requires knowledge and experience with biologics, drug development, CDMO and test laboratory management, and the international regulatory landscape.

The successful candidate must also demonstrate technical expertise in the areas of responsibility. *Title commensurate on experience.

SPECIAL ADVISORY

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com, please Report any Scams

THE RESPONSIBILITIES

• Provide and champion QA’s perspective and requirements in team meetings.
• Review and approve lot release documentation, including Certificates of Analysis, batch records, deviation reports.
• Oversee the lot release process to ensure compliance with regulatory requirements (e.g. FDA, EMA) and internal quality standards.
• Review and approve deviations initiated from contract manufacturer organizations.
• Partner with CMC and clinical teams to ensure a continuous supply of quality product is available for clinical studies.
• Establish and manage robust processes to ensure end-to-end product quality.
• Identify key product quality issues and risks and present issues and proposed solutions to management.
• Maintain quality systems to ensure compliance with Good Manufacturing Practices (GMP).
• Participate in internal / external audits and participate in regulatory inspections to ensure ongoing compliance.
• Provide technical expertise, recommendations and make complex quality decisions without compromising safety or compliance.
• Support product regulatory filings by driving clarity and consistency with specifications and CQAs.
• Drive phase appropriate readiness, support product transition from clinical to commercial, new product introductions and tech transfers.
• Provide expert review and quality approval of technical documents and quality agreement.

THE QUALIFICATIONS

• BS degree in a scientific discipline.
• 8+ years (Associate Director), 10+ years (Director) of experience in biotech, pharmaceutical or related industry; or the equivalent combination of experience and education / training with a minimum of 6 years in a quality assurance role.
• Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
• Understanding of product lot release and associated quality systems.
• Experience with deviation management in a biologics manufacturing environment.
• International / global experience preferred with demonstrated knowledge of cGMPs and global Health Authority Regulations.
• Technical expertise in DS / DP / FG manufacturing processes and skilled in quality management of CDMOs and testing laboratories.
• Familiarity of biologics and small molecules, devices, and combination products desirable with deep knowledge and understanding of the drug development process, process validation, and related regulatory guidance.
• Strong written and oral communication skills and the ability to communicate complex concepts across all levels of the organization including active and respectful engagement during meetings.
• Consistently demonstrated sound quality judgment and focus on patient safety and regulatory compliance.
• Proven success influencing decision makers and utilizing sound problem solving skills to recommend options and implement effective solutions.
• Experience in developing streamlined process for approval of documentation with CMDO’s and external partners.

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 $175,000 - 230,000 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