Immunome, Inc. · 1 week ago
Senior Director, CMC Technical Lead
Bothell, WA
Full-time
Onsite
Director/Executive
$234K/yr - $282K/yr
10+ years expImmunome, Inc. is a clinical-stage targeted oncology company committed to developing innovative cancer therapies. They are seeking a highly experienced CMC leader to oversee the Chemistry, Manufacturing, and Controls strategy for varegacestat, ensuring successful NDA and MAA submissions and product launches.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
Define and lead the overall CMC strategy for varegacestat, encompassing drug substance, drug product, analytical, regulatory, and supply chain elements to enable successful NDA/MAA submissions, launch readiness, and lifecycle management
Foster a collaborative and supportive CMC team environment that encourages open communication, knowledge sharing, and mutual accountability
Translate program objectives into clear CMC plans and priorities, ensuring alignment, coordination, and accountability across all CMC functional areas (e.g., Product Supply, Drug Substance, Drug Product, Analytical, Quality, Regulatory)
Represent CMC on the Global Product Team (GPT) and act as the central point of contact between the GPT and Technical Operations to ensure seamless integration of CMC deliverables into the overall development and commercialization plan
Provide strategic oversight to CMC functional leads to ensure that program goals are delivered on time, with 'first time right' execution, and consistent with Quality and Regulatory expectations
Contribute to overall product strategy development, including but not limited to: Global product launch planning and timing. Line extension and lifecycle strategies to provide continued patient value and mitigate generic risk. Long-term product evolution planning in collaboration with Commercial and R&D teams
Collaborate with Product Supply to develop varegacestat supply chain strategy and risk management, ensuring the establishment of a resilient and redundant supply network appropriate to each stage of development and commercialization
Collaborate with Product Supply and QA to ensure robust monitoring and governance of Continued Process Verification (CPV) of varegacestat operations, via compliance and performance metrics
Collaborate with CMC Regulatory Affairs to establish regulatory strategy, coordinate authoring and review of CMC documentation, and ensure timely submission and response readiness
Integrate functional inputs into comprehensive CMC plans, ensuring budgets, timelines, and deliverables are realistic, resourced, and aligned with corporate priorities
Provide periodic dashboard summary to Tech Ops management, including but not limited to budget and spending status, COGS, forecast and demand versus inventory levels, and key manufacturing and product performance metrics
Identify and communicate CMC risks and mitigations, escalating as appropriate to ensure proactive issue management and decision-making
Drive alignment between technical and business objectives, ensuring CMC activities enable both regulatory success and commercial value realization
Stay current with industry trends, emerging technologies, and regulatory developments to inform strategy and continuous improvement
Qualification
Required
Ph.D., M.S., or B.S. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline
Minimum of 10 years of experience in CMC development for small molecule therapeutics, with at least 5 years in a leadership role
Proven experience leading CMC teams through late-stage development, NDA/MAA submissions, and commercial launch
Strong understanding of solid oral dosage form development, process validation, and commercial manufacturing
Expertise in regulatory submissions (Module 3) and responding to agency queries
Demonstrated ability to ensure vendor performance and compliance through effective oversight and collaboration
Proven track record of delivering results on time and right the first time, fostering accountability and excellence across teams and partners
Excellent leadership, communication, and strategic planning skills
Company
Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$998.85MKey Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M
Leadership Team
Clay Siegall
President and CEO
Purnanand D. Sarma
President & CEO
Recent News
2026-01-09
BioWorld Financial Watch
2025-12-19
Company data provided by crunchbase