Head of CMC

Job Description

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 to own 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 escalate early.
• Regulatory CMC & Health Authority Strategy: Own the CMC regulatory strategy and the quality and consistency of CMC content for INDs, IMPDs, CTAs, and related clinical-stage US and global submissions, author and lead Module 3 for the IND, the IMPD Quality sections, and subsequent CTAs. Prepare CMC content for pre-IND and Type B/C meeting packages, respond to health authority questions, and keep development aligned with ICH expectations and agency precedent for multi-specific formats. Build the early-phase package so it scales cleanly into late-phase development and, ultimately, a BLA.
• Quality Compliance & Inspection Readiness: In partnership with Quality, set phase-appropriate GMP expectations and oversee quality agreements, CDMO performance, deviations, investigations, CAPAs, change control, data integrity, and batch disposition readiness. Build the documentation, systems, and inspection discipline needed for clinical development without importing unnecessary late-stage process burden into an early-stage company.
• Financial & Business Leadership: Develop long-range CMC financial forecasts and resource plans; own operating budgets, statements of work, purchase commitments, and change orders; and make disciplined recommendations on capital allocation and technical risk. Provide CMC leadership for partnering, licensing, financing, and due diligence activities, including clear articulation of value, risk, readiness, and future investment needs.
• Organization & Capability Building: Design the CMC organization and operating model for the company's stage and pipeline. Build and lead a high-performing team of employees and consultants, establish clear accountability and governance, and implement scalable ways of working for data review, documentation, knowledge management, decision records, vendor oversight, and cross-functional execution.
• Cross-Functional Collaboration & Risk: Partner with Research/Biotherapeutics on developability and candidate selection, influencing molecule design before it is locked. Support tox and clinical supply planning with Nonclinical and Clinical Operations. Identify and mitigate technical, supply, and regulatory risks, and contribute CMC content to diligence for partnering and financing.

Required Qualifications:  

• Bachelor’s or advanced Degree in biochemistry, biology, immunology, biotechnology, chemical or bioprocess engineering, chemistry, pharmacy, or a related field.
• Typically 15+ years of progressively responsible biologics CMC experience or technical operations experience, including meaningful accountability as the functional or enterprise leader. Candidates with BS/MS will generally bring approximately 18-20+ years of experience; candidates with a PhD will generally bring approximately 12-15+ experience.
• A career built on recombinant antibody and protein therapeutics, including direct, substantive experience developing antibody-based multi-specifics. Bispecific experience is required; tri-specific or other multi-domain format experience is a strong differentiator.
• Ideal candidate will have demonstrated hands-on depth in at least one of: (a) CHO cell line development and upstream/downstream process development for complex biologics, or (b) analytical development and characterization of complex biologics — with credible working fluency in the other.
• Experience with IND or IMPD filings for a biologic in which you personally owned or co-owned the CMC sections, and at least one GMP drug substance and drug product campaign delivered under your accountability.
• Proven ability to deliver CMC entirely through external partners: CDMO selection, technology transfer, campaign oversight, and technical troubleshooting without an internal plant or a large internal team.
• Strong development and CMC project management capability: you have personally built and defended integrated CMC timelines and budgets, managed critical path against a filing date, and driven cross-functional programs to schedule.
• Fluency in phase-appropriate GMP and ICH quality expectations, with the judgment to apply early-phase rather than commercial standards.
• A builder-operator mindset: comfortable moving between enterprise strategy, Board-level discussion, partner governance, and detailed review of the data and documentation needed to make sound decisions.
• Clear, direct written and verbal communication; able to convey a CMC risk to a board and a technical requirement to a CDMO with equal precision.

Preferred Qualifications:

• Direct experience with Tri-specific antibodies, T-cell or NK-cell engagers, or other formats with substantial mispairing and impurity-control challenges.
• Bioassay and potency assay development for dual- or multi-target mechanisms of action.
• Direct interaction with FDA and EMA (pre-IND, Type B/C, scientific advice), particularly on multi-specific CMC questions.
• Non-GMP tox material supply and the transition into first GMP manufacture.
• Experience with clinical-stage CMC development, including comparability across campaigns, inspection readiness, process changes, or scale-up in support of ongoing clinical supply.
• Experience managing CDMO and supply networks across the United States, Europe, and Asia-Pacific.
• CMC leadership in partnering, licensing, financing, or investment diligence, including support of executive and Board discussions.

Expected Salary Range : $277,520-416,280

We encourage candidates of all levels to apply as there is sometimes flexibility on job level and responsibilities. Compensation will be based on a variety of factors, including experience, qualifications, internal equity, and location.  

ImmunEdge offers a competitive employment package that includes an annual bonus plan, equity, and a generous benefits package including comprehensive health (medical, dental, and vision) insurance for our employees and their families, a 401k plan, FSA plans (medical, dependent), an Employee Assistance Plan, and a holiday and paid time off plan.  

At ImmunEdge, we believe that a diverse, open, and inclusive environment and culture is key to our success.  We will not be influenced in recruiting, hiring, promoting or any other employment practices by race, color, citizenship status, national origin, ancestry, sex, sexual orientation, gender identity/expression, age, religion, physical or mental disability, medical or genetic condition, marital status, veteran status, or any other characteristics protected under applicable federal, state and local laws. ImmunEdge will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable laws. 

Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation. 

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