What are the responsibilities and job description for the Associate Director, Upstream Process Development position at Immunome?
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 innovative Associate Director to build and lead the Upstream Process Development function and manage the mammalian cell culture process development activities for our fast-growing pipeline. This role is responsible for overseeing the development of phase appropriate cell culture processes, technology transfer, and successful execution of the developed processes at GMP manufacturing facilities. The successful candidate will play a pivotal role in advancing Immunome's innovative pipeline through all stages of development. The ideal candidate will possess extensive knowledge in state-of-the-art cell culture production technologies, and a proven track record of delivering regulatory acceptable processes right-the-first time.
Responsibilities
- Lead the Upstream Process Development team by setting strategic goals, timelines, and priorities to advance pipeline projects and drive process optimization.
- Establish in-house upstream process development capabilities.
- Develop robust, GMP-scalable upstream manufacturing processes that meet regulatory standards and ensure reproducibility.
- Design and implement an in-house fed-batch cell culture platform with a titer yield exceeding 6 g / L and acceptable product quality.
- 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 upstream process development, biologics 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 Upstream Process Development function, ensuring optimal support for organizational goals.
Qualifications
Knowledge and Skills
Washington State Pay Range
174,547-$200,490 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.
Salary : $174,547 - $200,490
