Head of CMC

ImmunEdge, Inc; Redwood City (CA); On-site; USD 300,000 - 380,000; Full time

Job summary

ImmunEdge, Inc. is seeking a Head of CMC to own the technical strategy and execution that carries our molecules from research-grade material to GMP clinical supply.

You will lead CMC strategy, governance, budget, and delivery across the portfolio, reporting to the EVP of R&D and the board. As a senior member of the R&D leadership, you will coordinate with CDMOs, external labs, and QA to ensure compliant manufacture, analytical development, and regulatory submissions.

Qualifications

• Strong strategic leadership in CMC for biologics programs.
• Experience coordinating with CDMOs and external labs to deliver GMP-compliant product
• Knowledge of regulatory CMC requirements and IND/CMC submissions

Responsibilities

• Define and own enterprise CMC vision and strategy across the portfolio.
• Lead end-to-end product development and technical operations from developability to GMP manufacturing.
• Oversee analytical development, characterization, and regulatory submissions.
• Manage external partners, budget, and timeline with executive reporting.

Job description

Location: Redwood City, CA

Level: Vice President/Senior Vice President, commensurate with the breadth of portfolio leadership, organizational scope, and experience.

Company Overview

ImmunEdge is a biopharmaceutical company committed to developing novel therapeutics for patients with serious or life-threatening diseases. With a highly experienced team of experts in immunology and drug development, we are pioneering innovative approaches to target and modulate key molecular pathways that regulate the immune response.

At ImmunEdge, we are driven by a shared commitment to improving human health through innovative science. We are building a culture based on kindness, collaboration, and a deep passion for advancing science. As an early joiner to the company, you will help cultivate an environment where every team member is encouraged to challenge ideas, think critically, and contribute their unique perspectives. We value openness, transparency, and continuous learning, and want to empower our employees to take ownership of their work while fostering a sense of community and teamwork. Whether you’re working in the lab, the office, or across functional teams, you will find an inclusive space where your contributions matter and your professional growth is supported.

Join us in shaping the future of biotechnology. Together, we can change lives.

Position

Reporting to the EVP of R&D, the Head of CMC owns the technical strategy and the hands-on execution that carries our molecules from research-grade material to GMP clinical supply and all related regulatory filings.

As a senior member of the R&D leadership team and a key advisor to the executive team and Board, this leader will own CMC strategy, governance, investment priorities, risk, budget, and delivery across the portfolio. The role requires clear recommendations on technical and business tradeoffs and ensures that CMC decisions are aligned with clinical, financing, partnering, and company value-creation milestones.

There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical details—including reviewing development reports, interrogating a chromatogram, troubleshooting technical issues, and authoring Module 3.

Candidates will have a strong expertise in antibody-based multi-specifics — bispecifics and, ideally, tri-specifics. Scope covers CMC strategy, cell line and process development, analytical development and characterization, formulation, external manufacturing and supply, and the CMC sections of regulatory submissions. The Head of CMC sets phase-appropriate GMP expectations and oversees CDMO quality performance and Quality Assurance.

Key Responsibilities

• Executive CMC Strategy & Portfolio Governance: Set toown the enterprise CMC vision and strategy across the portfolio, sequenced against corporate value inflection points and financing milestones. Make and defend phase-appropriate calls on what must be locked before the GMP campaign and what can responsibly wait. Report CMC status, risk, cost, and timeline to the executive team and board.
• End-to-End Product Development & Technical Operations: Lead the integrated CMC strategy from developability and candidate selection through cell line development, upstream and downstream process development, analytical development and characterization, formulation, drug substance and drug product manufacture, stability, comparability, clinical supply, scale-up, and technology transfer into GMP manufacturing. Direct cell line development through stable pool generation, single-cell cloning, clonality documentation, and MCB/WCB manufacture and testing. Oversee upstream and downstream development with explicit focus on resolving and controlling multi-specific product-related impurities (homodimers, half-molecules, mis-paired species, HMW/LMW) alongside viral clearance, UF/DF, and developability (aggregation, viscosity, self-association) into a stable formulation. Own scale-up and technology transfer into the GMP facility.
• Analytical Development & Characterization: Oversee analytical package. Establish the reference standard, phase-appropriate method qualification, the stability and forced-degradation program, initial specifications, and the comparability strategy.
• Program & Project Management: Build and own the integrated CMC program plan: a single resource-loaded timeline spanning cell line development, upstream, downstream, analytical, formulation, DS and DP manufacture, and stability, with the critical path to IND. Run stage-gate reviews, maintain the risk register with mitigations and scenario plans, and manage campaign readiness end to end — tech transfer packages, batch record review, person-in-plant, deviation and investigation follow-through. Forecast and control the CMC budget, statements of work, and change orders.
• External Manufacturing & CDMO Management: Select, qualify, and manage CDMOs and contract laboratories for drug substance, drug product, fill/finish, testing, packaging, labeling, and clinical distribution. Negotiate scope and terms, hold partners to schedule and quality, and elevate early.
• Regulatory CMC & Health Authority Strategy