Associate Director, Purification Process 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.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.

Position Overview

We are seeking an experienced and innovative Associate Director to establish and lead the Purification Process Development function, managing purification development activities to support our expanding pipeline. This role will be responsible for developing phase-appropriate purification processes, overseeing technology transfer, and ensuring successful execution of these processes at GMP manufacturing facilities. The successful candidate will be instrumental in advancing Immunome’s innovative pipeline through all stages of development. The ideal candidate will bring deep expertise in cutting-edge purification technologies and a proven track record of delivering regulatory-compliant processes right the first time.

Responsibilities

• Lead the Purification Process Development team by setting strategic goals, timelines, and priorities to advance pipeline projects and drive process optimization.
• Establish in-house purification development capabilities.
• Develop robust, GMP-scalable purification manufacturing processes that meet regulatory standards and ensure reproducibility.
• Design, implement, and continuously improve an in-house purification platform process to enhance performance and efficiency.
• Oversee outsourced development and manufacturing activities within the company’s portfolio, ensuring alignment with internal goals and quality standards.
• Lead technology transfer efforts, providing technical oversight to ensure smooth manufacturing operations.
• Direct the creation of essential documentation (SOPs, protocols, reports) to support regulatory submissions and technology transfers.
• Stay informed of emerging trends in purification process development, biological production, and regulatory requirements, integrating these insights into the company’s strategy.
• Mentor, coach, and develop scientists and technical staff, fostering a high-performance and collaborative team culture.
• Manage resource allocation, budgets, and timelines for the Purification Process Development function, ensuring optimal support for organizational goals.
  
  

Qualifications

• D., Master’s, or Bachelor’s degree in Chemical/Biochemical Engineering, Biotechnology, Biochemistry, Biological Sciences, or a related field.
• Minimum of 7 years of experience with a PhD, 10 with a Master’s, and 13 with a Bachelor’s in purification process development for biopharmaceutical production is required. Previous experience serving in a leadership role managing programs and teams is strongly preferred.
• Demonstrated success in developing and optimizing purification processes for monoclonal antibodies and recombinant proteins is required.
• Experience in regulatory submissions, responding to information requests, and interfacing with health authorities.
• Up to 20% travel and occasional work outside of business hours may be required.
  
  

Knowledge And Skills

• Proven leadership experience in purification process development across all stages of drug development.
• Deep expertise in purification process technologies, driving continuous improvement in capabilities, methods, and equipment.
• Thorough understanding of GMP standards and regulatory guidelines, with hands-on experience supporting IND, BLA, or MAA submissions.
• Excellent judgment and the ability to balance hands-on tasks with strategic oversight.
• Adaptable to ambiguity and complex challenges; able to lead teams confidently in dynamic environments.
• Strong leadership and people management skills, fostering a high-performance, collaborative team culture.
• Outstanding communication skills with the ability to effectively collaborate across functions.
• Solution-oriented problem-solving abilities, with the skill to manage multiple projects and prioritize effectively in a fast-paced environment.
  
  

Washington State Pay Range

$188,773 - $223,581 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.