Vice President, Head of CMC

Repertoire Immune Medicines•Cambridge, MA

1d•Hybrid

About The Position

Repertoire Immune Medicines is seeking an accomplished and strategic Vice President, Head of CMC to lead all Chemistry, Manufacturing, and Controls activities across the company’s growing pipeline of protein biologics. This senior leader will be responsible for establishing and executing CMC strategy from development candidate nomination through clinical development. The successful candidate will bring deep expertise in biologics CMC development, demonstrated success building teams and processes in both early‑stage and mature organizations, and a strong track record of technology transfer and management of external manufacturing organizations. This leader will work cross‑functionally with research, preclinical, clinical, regulatory, quality, and finance teams to ensure successful execution of CMC activities related to regulatory filings, cGMP manufacturing and clinical supply.

Requirements

PhD in Biochemistry, Biology, Biotechnology, Chemical Engineering, Biological Engineering, or a related discipline.
15+ years of experience in the pharmaceutical or biotechnology industry, with substantial leadership responsibility in biologics CMC, process development, and manufacturing.
Recognized expert in biologics CMC process, development, and strategy, including application of Quality by Design (QbD) approaches to support robust manufacturing processes and consistent product quality across development stages.
Proven experience building and leading teams and developing talent in matrixed and outsourced environments.
Extensive experience with technology transfer to CDMOs, including cell line development, upstream and downstream process development, analytical method development, scale‑up, and GMP manufacturing.
Hands‑on experience with formulation development and stability studies for drug substance and drug product to support regulatory submissions and clinical trials.
Strong working knowledge of drug development across research, preclinical, clinical, and regulatory functions.
Demonstrated ability to author high‑quality technical documentation for regulatory submissions.
Exceptional leadership, communication, and stakeholder management skills, with the ability to drive strategic discussions with senior management and external partners.
Proven ability to build consensus and solve complex problems across diverse, cross‑functional teams.
Willingness to travel domestically and internationally as needed to support CDMO oversight.

Nice To Haves

Experience with bispecific proteins, Fc‑fusion proteins, or other complex biologics preferred.

Responsibilities

Define and execute end‑to‑end CMC strategy aligned with corporate and clinical development objectives.
Lead and develop a high‑performing Technical Development Team encompassing upstream, downstream, analytical, and formulation development.
Serve as the primary CMC leader for development candidate selection and progression decisions.
Identify, select, and manage CDMOs and CROs; negotiate manufacturing, quality, and supply agreements in partnership with executive leadership and finance.
Lead seamless technology transfer of manufacturing and analytical processes to external partners for non‑GMP and GMP production.
Oversee drug substance and drug product manufacturing from development candidate nomination through clinical supply, ensuring on‑time delivery for regulatory submissions and clinical trials.
Monitor manufacturing timelines, budgets, and performance; proactively identify opportunities to accelerate development and control costs.
Establish critical quality attributes (CQAs), process controls, and fit‑for‑purpose control strategies to ensure product consistency and robustness.
Oversee analytical method transfer, method qualification, stability programs, and product shelf‑life assignments.
Provide leadership and oversight of QA activities with external QA consultants and quality systems appropriate for company stage.
Oversee clinical labeling, packaging, and supply logistics through supervision of clinical supply partners.
Review technical documentation and reports from CDMOs and CROs.
Author and oversee CMC sections of regulatory submissions and amendments.
Partner closely with Regulatory Affairs to support health authority interactions related to CMC.
Develop CMC operating plans, milestones, and short‑ and long‑term objectives across all pipeline programs.
Build scalable systems and processes appropriate for company growth.
Influence company culture through collaborative leadership, mentorship, and cross‑functional partnership.