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 Reporting into the Senior Director, CMC Quality Assurance, the Associate Director/Director, 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 will 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. 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 agreements 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 salary and level. These considerations mean actual salary and level may vary. The expected salary range for this position based on the primary location for this position in Northern California is $175,000 – $230,000. 89bio’s role/level assessment approach involves assessing candidates during the interview process before confirming the level/title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as: education, experience, qualifications, geographic location, transferable skills, licenses/certifications and other job-related factors permitted by law. 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 CONDITIONS OF EMPLOYMENT Background investigations are required for all positions by 89bio, consistent with applicable law. We require all employees to be fully vaccinated against COVID-19, as part of our commitment to ensuring a safe workplace for our team. Proof of vaccination will be required. Reasonable accommodations will be considered for individuals with medical or religious exemptions, in accordance with applicable laws. 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.

#J-18808-Ljbffr