Senior Manager/Associate Director, Quality Assurance

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 an experienced Senior Manager/Associate Director, Quality Assurance to support our Small Molecule and Antibody Drug Conjugate (ADC) portfolio. This role will be responsible for overseeing the batch record review, change controls, deviations, CAPAs and other aspects of QA operations, associated with batch release. This individual will work closely with the Contract Manufacturing Organization (CMO) to release Intermediate/RSM, drug substance, drug product and finished drug product. This position collaborates with internal and external stakeholders to ensure quality and regulatory compliance throughout the different manufacturing stages.

Responsibilities

• Quality representative on multiple product cross-functional teams
• Review and approve records/documents including but not limited to validation protocols and reports, transfer documents, change controls, deviations, CAPAs, product. specifications, technical reports, stability protocols, product complaints and temperature excursion related documentation.
• Onboard and monitor suppliers/vendors associated with program.
• Oversee quality performance of third-party supplier’s services (manufacturing, filling, packaging, and storage/shipping) and maintain regular oversight via periodic monitoring, auditing, and quality agreement reviews.
• Contribute to or make product quality decisions.
• Responsible for product disposition.
• Contributes to the development and maintenance of a positive team-focused company culture and a culture of quality by collaborating across all departments to accomplish company objectives.
• Supports regulatory inspections and internal audits, including gap identification and closure for inspection readiness.
• Supports the continuous improvement of processes and systems to assure the quality of products. Lead, provide input and change management for quality improvements.
• Supports implementation of Quality Management System processes.
• Position may require domestic and international travel (up to 15%).
  
  

Qualifications

• The position requires a Bachelor’s degree, or equivalent, preferably in a Life Science field.
• Minimum of 7 years of experience in the pharmaceutical industry within Quality Assurance, with a minimum of 5 years working with biologics, ADCs preferred.
• Minimum of 3 years of experience working with CMO/CDMO partners, required.
  
  

Knowledge And Skills

• Demonstrated track record of third-party supplier management.
• Experience managing quality oversight for development products.
• Demonstrates initiative and proactively provides collaborative support to the internal and external stakeholders as a credible communicator.
• Must have high degree of professionalism, and ability to work with limited direction to follow through with specific tasks.
• Continuously demonstrates a positive, and service-oriented attitude.
• Strong oral and written communicator; detail-oriented with a commitment to accuracy.
• Ability to plan and organize work in an efficient manner, multi-task, and shift priorities quickly while working under time constraints.
• Skilled in developing collaborative internal and external relationships.
  
  

Washington State Pay Range

$165,000 - $194,386 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.