Senior Director, CMC Technical Lead

Immunome, Inc.•Bothell, WA

3d•$234,000 - $281,742

About The Position

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets. We are seeking a highly experienced CMC leader to oversee the Chemistry, Manufacturing, and Controls (CMC) strategy and execution for varegacestat. This individual will lead the CMC team through NDA and MAA submissions, enable on-time product launch and sustained commercial supply, support ongoing clinical development, and drive second-generation drug product initiatives. The ideal candidate will demonstrate strong strategic and operational leadership, ensuring all CMC and product lifecycle deliverables are achieved on time, with 'first time right' execution, and in alignment with global commercial and technical objectives. This is a leadership role reporting to the Head of Chemical Process and Analytical Development.

Requirements

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.

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.