Director/Sr Director, CMC Technical Lead

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. 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 targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

Position Overview

We are seeking a highly experienced and motivated individual to lead our ADC CMC teams. You will play a key role in the strategic direction, planning, and execution of development programs. As a CMC lead, you are responsible for overseeing all Chemistry, Manufacturing, and Controls (CMC) aspects of an ADC program, leading a team of scientists to develop and execute manufacturing processes for drug substance and drug product, ensuring Quality and Regulatory compliance throughout the development cycle, while being a key collaborator on the Global Product Team (GPT) to drive program forward. This is an individual contributor role, and the position reports to the head of Technical Operations.

Responsibilities

• Develops the overall CMC strategy to support program objectives.
• Leads CMC Team and represents CMC on Global Product Team.
• Serve as the central point of contact between GPT and Tech Ops functions.
• Provides Tech Ops input into the development of the asset lifecycle strategy.
• Empower technical representatives to plan and execute functional area objectives but owns cross-functional CMC decisions and is accountable for overall CMC deliverables .
• Ensures CMC Plan is aligned and integrated into the integrated project plan .
• Leads identification, assessment, mitigation and escalation of CMC risks.
• Partners with CMC Regulatory to develop regulatory strategy for the program.
• Lead the preparation and reviews of CMC sections and regulatory submissions .
• Accountable for ensuring supply strategy to meet Product strategy .
• Maximizes CMC Team performance through collaboration, delegation and empowering team members, positive team dynamics, effective communication and resource management .
• Partner with PM and functional area leads to develop budget and is accountable for budget adherence.
• Partner with CMC functional leads to drive optimization of manufacturing process to ensure scalability, efficiency, and cost-effectiveness.
• Collaborate with cross-functional teams, including Finance, Legal, Research, Translational Sciences, Clinical Development, Regulatory, Quality, Program Management, and Commercial to ensure seamless integration and execution of CMC as part of development program.
• Stay current with industry trends, technologies, and regulatory requirements for ADC drug development.
• Communicate program updates, challenges, risks, and successes to senior leaderships and key stakeholders.
• Build strong relationships with internal and external partners including CROs, CDMOs, and suppliers.
  
  

Qualifications

• PhD, Master’s, or Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, or related field with a focus on biologics development.
• A minimum of 8 years of relevant experience in the biopharmaceutical industry with a PhD, 10 with a Master’s, or 12 with a Bachelor’s degree. Experience specifically in process & analytical development and/or manufacturing of biologics is required; ADC experience is a plus.
• Proven track record of leading CMC teams from research to FIH and from late-stage development to commercialization.
• Proven track record of excelling in at least one technical area within CMC.
• Excellent leadership, project management, and communication skills.
  
  

Knowledge And Skills

• In-depth understanding of the critical quality attributes (CQAs) and control strategy of biologics, specifically ADCs.
• Working knowledge of regulatory requirements for clinical and commercialization of sterile drug products.
• Strong analytical and problem-solving abilities with a focus on innovation and continuous improvement.
• Excellent interpersonal skills and ability to work in a multidisciplinary team environment.
• Ability to manage multiple projects with tight deadlines and priorities.
• Strong strategic planning and decision-making skills.
  
  

Washington State Pay Range

$226,918 - $271,625 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.