Associate Director, Drug Product Development

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 join our Drug Product Development team. As key member of ADC Drug Product Development team, you will lead the development, and optimization of ADC formulations and drug product processes from preclinical stages through commercial manufacturing. You will play a key role in the strategic direction, planning, and execution of projects related to Drug Product, ensuring that they meet both scientific and regulatory standards

Responsibilities

• Lead Drug Product development projects to design and optimize formulations for antibody-drug conjugate products.
• Collaborate with external partners, contract development and manufacturing organizations (CDMOs) to support pipeline development and drive innovation in drug product technologies.
• Play a key role in the development of robust and scalable formulations that maintain ADC stability, efficacy, and safety.
• Lead optimization of fill-finish processes, including aseptic handling, lyophilization, and compatibility with delivery systems
• Lead innovation initiatives in formulation technologies to improve efficiency and deliver safe and efficacious drug products.
• Provide scientific leadership in addressing technical challenges related to drug product manufacturability and stability.
• Collaborate with cross-functional teams, including Analytical Development, Drug Substance Process Development, Manufacturing, and Quality, to ensure seamless integration of Drug Product strategies across all phases of development.
• Lead troubleshooting and process optimization efforts to resolve technical challenges related to formulations, stability, and scalability.
• Manage the preparation of technical reports, documentation, and regulatory submissions to support clinical development and commercialization.
• Stay current with industry trends, technologies, and regulatory requirements for ADC drug product formulations and emerging technologies.
• Mentor, develop, and manage a team of scientists, ensuring high performance and professional growth.
  
  

Qualifications

• PhD in Biochemistry, Chemistry, Chemical Engineering, or related field with a focus on drug product development for biologics.
• Minimum of 8 years of relevant experience in the biopharmaceutical industry, specifically in the development of Drug Product, preferably ADC Drug Product.
• Proven track record of leading successful drug product and formulation development projects from early-stage research through late-stage development and commercialization.
• Good understanding of ADC-specific challenges, including linker-payload chemistry, conjugation, and stability is a plus
• Experience working in a GMP environment and a strong understanding of regulatory requirements for bioconjugates.
• Excellent leadership, project management, and communication skills.
  
  

Knowledge And Skills

• In-depth understanding of the critical quality attributes (CQAs) of drug product for ADC, and experience with DP process development, fill/finish, and tech transfer.
• Experience in ADC and biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to clinical and commercial manufacturing.
• Good understanding of analytical methods and product attributes for ADCs.
• Working knowledge of regulatory requirements for clinical and commercialization of sterile drug products, including application of Quality by Design principles.
• 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.
  
  

Washington State Pay Range

$176,394 - $206,824 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.