Job Title: Associate Director / Director, Process Development and MSAT – Biologics Manufacturing

Department: CMC

Reports To: VP, Pharmaceutical Development & Manufacturing

Location: Hybrid - Remote and In-Office (South San Francisco)

Job Description: Spruce Bio is seeking an experienced Associate Director / Director, Process Development to lead biologics process development and external manufacturing activities across our pipeline. This is a senior, highly visible role with end-to-end accountability for upstream and downstream process strategy, CDMO and vendor oversight, and successful delivery of formulated bulk drug substance for clinical and commercial supply. Oversight of CDMOs requires (20-30%) travel to the sites. The ideal candidate has built and scaled biologics processes through GMP manufacturing, managed multiple CDMOs concurrently, and is comfortable operating as the primary technical and operational point of contact for external partners. This role provides technical direction, manages program-level budgets and timelines, and represents CMC in cross-functional governance and regulatory interactions. The role is a blend of scientific leadership, vendor and partner management, and strategic program execution — with meaningful impact on patient timelines.

Responsibilities:

Strategic process development & program leadership

• Own end-to-end upstream and downstream process strategy for all Spruce biologics programs (recombinant proteins including mAbs, enzymes, and fusion proteins)
• Define process development roadmaps from cell line through commercial-scale manufacturing, balancing speed, cost, quality, and regulatory risk
• Lead process characterization, validation, and lifecycle management strategy in alignment with ICH Q8/Q9/Q10/Q11 and global regulatory expectations
• Set technical direction for process improvements, second-generation processes, and platform development
• Lead troubleshooting and continuous improvement for both upstream (cell culture, fermentation, harvest) and downstream (chromatography, UF/DF, viral filtration, formulation) unit operations
• Evaluate and guide CDMO selection of new technologies (e.g., perfusion, continuous processing, single-use technology, advanced chromatography modes)
• Oversee process performance trending, annual product reviews, and process validation lifecycle planning to enable future commercial readiness

CDMO and external vendor management

• Lead CDMO selection: develop RFPs, evaluate proposals, conduct technical due diligence, and provide technical input into commercial terms negotiated by Procurement and Legal
• Manage CDMO performance against agreed KPIs (milestones, quality, cost, schedule); run regular operational reviews and escalate issues to executive leadership when needed
• Oversee tech transfer activities into CDMOs — direct the authoring and review of process descriptions, batch records, and tech transfer protocols
• Provide on-site and remote technical guidance during engineering, clinical, and commercial GMP campaigns; lead deviation investigations, root cause analyses, and CAPAs in partnership with Quality
• Manage suppliers of critical raw materials (chromatography resins, media, buffers, filters), including qualification, change control, and contingency planning
• Serve as the primary technical and operational point of contact for CDMOs, key external suppliers, and testing vendors (viral clearance (VC) and filter validation studies)

Regulatory and quality partnership

• Author and review CMC sections of regulatory submissions (IND, IMPD, BLA, MAA) and lead responses to health authority questions for process-related items
• Partner with Quality on change control, deviation management, and audit/inspection readiness; represent process development in regulatory inspections and CDMO audits
• Maintain a current understanding of evolving global regulatory expectations for biologics manufacturing

Requirements:

• Director: Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, Biotechnology, or related discipline with 10+ years of biologics process development and external manufacturing; OR M.S. / B.S. with 15+ years of equivalent industry experience
• Associate Director: Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, Biotechnology, or related discipline with 5+ years of biologics process development and external manufacturing; OR M.S. / B.S. with 10+ years of equivalent industry experience
• Demonstrated hands-on and leadership experience across both upstream and downstream process development for recombinant biologics
• Proven track record managing CDMO / CMO relationships through clinical-stage manufacturing, including selection, tech transfer, campaign oversight, and performance management
• Direct experience leading GMP manufacturing campaigns, including on-site presence, deviation management, and batch disposition support
• Strong working knowledge of cGMP, ICH guidelines (Q8/Q9/Q10/Q11), and global regulatory expectations for biologics CMC
• Experience contributing to IND, IMPD, and / or BLA submissions with CMC ownership
• Demonstrated experience managing technical scientists / engineers and program-level budgets
• Excellent written and verbal communication skills; comfortable presenting to executive leadership, partners, and health authorities

Preferred Qualifications:

• Experience with multiple modalities (e.g., mAbs, recombinant enzymes, fusion proteins, etc.)
• Demonstrated experience leading or supporting commercial-stage tech transfer and PPQ campaigns
• Familiarity with lyophilization process development and drug product formulation
• Working knowledge of single-use technology and continuous bioprocessing

About Spruce Bio: Spruce Bio is a dynamic and innovative biopharmaceutical company committed to transforming the lives of patients living with rare endocrine and related disorders by developing and commercializing novel therapies where there is significant unmet medical need. As we approach the anticipated first commercial approval of a product from our pipeline within the next year, we are scaling the company to support both commercial-stage and ongoing investigational programs. Our team is committed to scientific excellence, regulatory rigor, and delivering meaningful advancements to patients. We value collaboration, integrity, and a patient-centric approach in everything we do. Join us and be part of a team making a real impact in bringing novel therapies to patients with rare diseases.

Compensation & Benefits: In addition to the base salary and discretionary annual bonus program, as part of our total rewards program, Spruce offers a comprehensive employee benefits package, including a 401(k) plan with company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Spruce also offers employees the opportunity to purchase company stock and receive long-term equity incentives. Employees also receive up to 20 accrued vacation days, 10 paid holidays, a company-wide winter shutdown in December, and paid sick leave. Employees based in our South San Francisco office have access to an on-site full fitness facility, weekly team lunch, in-office coffee bar, snacks, and other workplace amenities to support well-being and productivity.

Equal Opportunity Employer: Spruce Bio is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, pregnancy, genetic information, marital status, national origin, age, disability, veteran status, or any other characteristic protected by applicable federal, state, or local law.

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