89bio, Inc.
Director of MSAT and CMC Operations
89bio, Inc., San Francisco, California, United States, 94199
THE COMPANY
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.
SPECIAL ADVISORY
The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams.
THE ROLE
Reporting to Executive Director CMC Operations, the Director of Manufacturing Sciences and Technology (MSAT) and Chemistry Manufacturing and Controls (CMC) Operations will be responsible for managing activities related to scientific and technical support of manufacturing processes. The position will lead the technical lifecycle for a microbial biologic process from late-stage development through commercial supply. The qualified candidate will be a key stakeholder supporting PPQ and CPV, resolve complex deviations, represent at CDMOs, and serve as CMC/MSAT author and resource supporting CMC for regulatory submissions. They will create and maintain process databases for trending and monitoring KPIs. The position will support the Company's drug development and manufacturing activities from clinical and commercial at external Contract Manufacturing Organization (CMO) and Contract Testing Labs (CTL.)
THE RESPONSIBILITIES
Partner with global CMOs and CTLs to optimize processes and ensure cGMP-compliant manufacturing and supply of drug substance intermediates and drug products. Develop and maintain a comprehensive process monitoring database and live Continued Process Verification (CPV) dashboard for all CQAs/CPPs with control limits. Collaborate with Regulatory and Quality functions to manage and implement process changes in compliance with global standards. Support process development and manufacturing of intermediates for existing and new development programs. Lead technology transfer and scale-up activities at CMOs, ensuring process reproducibility and compliance. Author, review, and approve technical documents for INDs and regulatory submissions as required. Review and approve validation protocols, reports, and specifications for drug substance and drug product manufacturing. Support process validation activities at CMOs at appropriate development stages, including review and approval of validation protocol designs. Travel as needed to CMO sites to ensure process alignment, implementation, and ongoing compliance. THE QUALIFICATIONS
S., M.S., or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, or a related field. 10+ years of industry experience in CMC operations or clinical/commercial manufacturing, with direct management of MSAT or process development activities. Proven expertise in statistical analysis and DoE (JMP, Minitab); strong understanding of ANOVA, regression, tolerance intervals, and control charts. Experience spanning late-stage development through commercialization is highly desirable. Broad knowledge of manufacturing platforms (e.g., small molecules, recombinant proteins, pegylation, drug products, combination devices). Demonstrated success managing CMO relationships, including deviation resolution, change controls, and OOS investigations. Experience collaborating with global external vendors (CMOs, CTLs) and managing technology transfers. Strong leadership and influencing skills, with the ability to drive accountability and alignment across internal and external teams. Exceptional problem-solving abilities, with a proven record of diagnosing complex issues and implementing effective, sustainable solutions. Excellent written and verbal communication skills, with the ability to convey complex technical concepts to diverse audiences. Experience working in high-growth, collaborative environments and effectively navigating change. Highly motivated, team-oriented, and execution-driven professional with strong organizational and interpersonal skills. Ability to work in the office two days of the week, Tuesdays and Wednesdays. 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 $196,000 - $235,000.
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 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. Candidates must already hold work authorization, as visa sponsorship is not available for this role.
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.
89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship.
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.
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.
SPECIAL ADVISORY
The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any group using a similar, but not our exact domain 89bio.com, please Report any Scams.
THE ROLE
Reporting to Executive Director CMC Operations, the Director of Manufacturing Sciences and Technology (MSAT) and Chemistry Manufacturing and Controls (CMC) Operations will be responsible for managing activities related to scientific and technical support of manufacturing processes. The position will lead the technical lifecycle for a microbial biologic process from late-stage development through commercial supply. The qualified candidate will be a key stakeholder supporting PPQ and CPV, resolve complex deviations, represent at CDMOs, and serve as CMC/MSAT author and resource supporting CMC for regulatory submissions. They will create and maintain process databases for trending and monitoring KPIs. The position will support the Company's drug development and manufacturing activities from clinical and commercial at external Contract Manufacturing Organization (CMO) and Contract Testing Labs (CTL.)
THE RESPONSIBILITIES
Partner with global CMOs and CTLs to optimize processes and ensure cGMP-compliant manufacturing and supply of drug substance intermediates and drug products. Develop and maintain a comprehensive process monitoring database and live Continued Process Verification (CPV) dashboard for all CQAs/CPPs with control limits. Collaborate with Regulatory and Quality functions to manage and implement process changes in compliance with global standards. Support process development and manufacturing of intermediates for existing and new development programs. Lead technology transfer and scale-up activities at CMOs, ensuring process reproducibility and compliance. Author, review, and approve technical documents for INDs and regulatory submissions as required. Review and approve validation protocols, reports, and specifications for drug substance and drug product manufacturing. Support process validation activities at CMOs at appropriate development stages, including review and approval of validation protocol designs. Travel as needed to CMO sites to ensure process alignment, implementation, and ongoing compliance. THE QUALIFICATIONS
S., M.S., or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, or a related field. 10+ years of industry experience in CMC operations or clinical/commercial manufacturing, with direct management of MSAT or process development activities. Proven expertise in statistical analysis and DoE (JMP, Minitab); strong understanding of ANOVA, regression, tolerance intervals, and control charts. Experience spanning late-stage development through commercialization is highly desirable. Broad knowledge of manufacturing platforms (e.g., small molecules, recombinant proteins, pegylation, drug products, combination devices). Demonstrated success managing CMO relationships, including deviation resolution, change controls, and OOS investigations. Experience collaborating with global external vendors (CMOs, CTLs) and managing technology transfers. Strong leadership and influencing skills, with the ability to drive accountability and alignment across internal and external teams. Exceptional problem-solving abilities, with a proven record of diagnosing complex issues and implementing effective, sustainable solutions. Excellent written and verbal communication skills, with the ability to convey complex technical concepts to diverse audiences. Experience working in high-growth, collaborative environments and effectively navigating change. Highly motivated, team-oriented, and execution-driven professional with strong organizational and interpersonal skills. Ability to work in the office two days of the week, Tuesdays and Wednesdays. 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 $196,000 - $235,000.
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 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. Candidates must already hold work authorization, as visa sponsorship is not available for this role.
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.
89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship.
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.