Senior Director/VP Manufacturing and CMC

POSITION SUMMARY

A well-funded, stealth-stage biotechnology company is seeking an experienced, hands-on Sr. Director / Vice President, Manufacturing and CMC. In this high-impact executive role, you will lead the operational execution and strategic direction of CMC activities for our pipeline of novel monoclonal and bispecific antibody programs.

We are at a pre-clinical stage and looking to advance multiple biologic assets into First-in-Human (FIH) Phase 1 and Phase 2 clinical studies over the course of our Series A funding. You will manage the execution of cell line development, formulation development, process development, and analytical development strictly in collaboration with our selected CDMO and CRO partners.

RESPONSIBILITIES

• Identify, select, and manage global CDMO and CRO partners. Directly oversee external execution of cell line development (CLD), upstream/downstream process development, formulation development, and analytical development for monoclonal and bispecific antibodies.

• Lead technical transfer, scale-up, and non-GMP/GMP manufacturing of Drug Substance (DS) and Drug Product (DP) to support non-clinical GLP toxicology studies and Phase 1/2 clinical trials.

• Direct CDMOs in developing stable liquid/lyophilized formulations and robust phase-appropriate analytical methods (characterization, release, and stability testing) tailored to complex bispecific and monoclonal antibody constructs.

• Author, review, and finalize early-stage CMC regulatory sections (Module 3, IND / CTA filings) for Phase 1/2 clinical study approvals.

• Provide hands-on technical oversight of CDMO/CRO activities. Review technical protocols, master batch records, analytical data, stability reports, and manage deviations, CAPAs, and change controls in partnership with Quality Assurance.

• Review and negotiate Statements of Work (SOWs), RFPs, and service agreements with external vendors. Manage the CMC operational budget to support efficient timeline delivery through Series A milestones.

• Serve as the primary CMC authority on internal leadership teams, translating technical progress, timelines, and risks clearly to executive leadership and scientific stakeholders.

EXPERIENCE & QUALIFICATIONS

• B.S., Master’s, or PhD in Biotechnology, Chemical Engineering, Biochemistry, Molecular Biology, or a related scientific discipline.

• Minimum of 12+ years (8+ with a PhD) in the biotechnology industry, with a proven track record of leading early-stage CMC operations for biologics (specifically monoclonal and/or bispecific antibodies).

• Extensive hands-on experience in early-stage development (Pre-clinical to Phase 1/2). Demonstrated success driving biologic assets from candidate selection through IND-enabling studies to initial clinical execution.

• Deep technical expertise in recombinant biologics, including mammalian cell line development (CHO), process development (DSP/USP), complex characterization of bispecific formats, and formulation optimization.

• Proven track record of selecting, contracting, and managing external CDMOs and CROs to deliver high-quality clinical supplies on tight timelines.

• Demonstrated experience authoring Module 3 / CMC sections for successful IND/CTA submissions.

• Exceptional communication and leadership skills with a "lead-by-example" mentality. Thrives in a fast-paced, lean, entrepreneurial startup environment where managing external execution is key.

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