Senior Director/VP Manufacturing and CMC
About The Position
A well-funded, stealth-stage biotechnology company at the preclinical stage is seeking a hands-on Senior Director / Vice President, Manufacturing and CMC. The role leads the operational execution and strategic direction of CMC activities for a pipeline of novel monoclonal and bispecific antibody programs. The company plans to advance multiple biologic assets into First-in-Human Phase 1 and Phase 2 studies during its Series A funding period. The position oversees cell line, formulation, process, and analytical development through selected CDMO and CRO partners. It provides technical and operational leadership for development, technology transfer, scale-up, and manufacturing of drug substance and drug product, and supports nonclinical GLP toxicology studies and clinical trials. The role also leads early-stage CMC regulatory work, vendor and budget management, and communication of CMC progress, timelines, and risks to executive and scientific stakeholders.
Requirements
- B.S., Master’s, or PhD in biotechnology, chemical engineering, biochemistry, molecular biology, or a related scientific discipline.
- At least 12 years of biotechnology-industry experience, or at least 8 years with a PhD.
- Proven experience leading early-stage biologics CMC operations, specifically for monoclonal and/or bispecific antibodies.
- Extensive hands-on experience in development from preclinical through Phase 1/2.
- Demonstrated success advancing biologic assets from candidate selection through IND-enabling studies to initial clinical execution.
- Deep technical expertise in recombinant biologics, including mammalian CHO cell line development, upstream and downstream process development, complex characterization of bispecific formats, and formulation optimization.
- Experience selecting, contracting, and managing external CDMOs and CROs to deliver clinical supplies on tight timelines.
- Experience authoring Module 3 / CMC sections for successful IND/CTA submissions.
- Exceptional communication and leadership skills, with a lead-by-example mentality.
- Ability to thrive in a fast-paced, lean, entrepreneurial startup environment where external execution is key.
Responsibilities
- Identify, select, and manage global CDMO and CRO partners.
- Oversee external cell line development, upstream and 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 and drug product for nonclinical GLP toxicology studies and Phase 1/2 clinical trials.
- Direct CDMOs in developing stable liquid or lyophilized formulations and phase-appropriate analytical methods for characterization, release, and stability testing.
- Author, review, and finalize early-stage CMC regulatory sections, including Module 3 and IND/CTA filings.
- Provide hands-on technical oversight of CDMO and CRO activities.
- Review technical protocols, master batch records, analytical data, and stability reports; manage deviations, CAPAs, and change controls with Quality Assurance.
- Review and negotiate Statements of Work, RFPs, and service agreements with external vendors.
- Manage the CMC operational budget to support timely delivery of Series A milestones.
- Serve as the primary CMC authority on internal leadership teams and communicate technical progress, timelines, and risks to executive leadership and scientific stakeholders.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
