Company Overview
Position Overview
Immunome is seeking an experienced Contract: Manager, CMC Stability Management and Analysis to oversee execution of outsourced stability programs. This contract role will be responsible for maintaining stability pull schedules, data review, and vendor oversight activities across mAb intermediate, drug substance, and drug product.
The successful consultant will bring practical expertise in GMP stability operations, biologics and large-molecule stability requirements, understanding of ADC stability indicating assays and outsourced laboratory management. This position requires a hands-on program manager who can translate technical and regulatory expectations into actionable plans, manage timelines and risks across external partners, and ensure stability deliverables are met.
Responsibilities
Study Execution and Operational Oversight
- Review stability protocols for long-term and accelerated studies.
- Create and maintain stability plans, master schedules, pull calendars, and study trackers across multiple development programs.
- Oversee execution of stability studies and ensure timely sample pulls, testing initiation, data delivery, and escalation of schedule or quality risks.
Data Review, Trending, and Technical Assessment
- Review stability data for completeness, accuracy, data integrity, trend behavior, specification compliance, and consistency with expected product quality attributes.
- Support evaluation of OOS/OOT results and atypical trends.
- Prepare stability summaries, trend reports, shelf-life assessments, retest/expiry recommendations, and technical risk assessments to support program decision-making.
Qualifications
- Bachelor’s or advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related field.
- 8+ years of experience in stability, QC, Analytical Development, CMC, or technical operations within the biotechnology or biopharmaceutical industry, or equivalent.
- Demonstrated experience managing GMP stability programs for biologics, monoclonal antibodies, fusion proteins, or other large molecules; ADC experience preferred.
- Hands-on experience with stability data review, trending, shelf-life assessment.
- Prior experience managing external CTLs, CDMOs, CROs, or stability storage vendors supporting regulated studies.
- Working knowledge of GMP requirements, data integrity expectations, ICH stability guidance, and regulatory expectations for biologics stability studies.
- Contract or consultant experience in a matrixed biotech environment preferred.
Knowledge and Skills
- In-depth understanding of biologics stability program management, including drug substance and drug product stability, retest/expiry dating, storage condition justification, and ongoing stability commitments.
- Working knowledge of ICH Q1A(R2), Q1B, Q1D, Q1E, Q5C, relevant FDA/EMA expectations, and phase-appropriate application of stability requirements.
- Strong understanding of biologics product quality attributes.
- Familiarity with analytical technologies used in biologics stability testing, including HPLC/UPLC, SEC, CE-SDS/cIEF/icIEF, ELISA, binding and potency assays.
- Strong project management skills with the ability to manage detailed schedules, multiple vendors, cross-functional dependencies, and competing program priorities.
- Ability to interpret stability trends, identify risks, escalate issues appropriately, and drive practical solutions in collaboration with technical and quality stakeholders.
- Excellent documentation, communication, and stakeholder management skills.
- Comfort with ambiguity and dynamic timelines; ability to operate independently and drive execution with limited supervision.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
Skills Required
- Bachelor's or advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or related field.
- 8+ years experience in stability, QC, Analytical Development, CMC, or technical operations within biotechnology/biopharmaceutical industry.
- Demonstrated experience managing GMP stability programs for biologics, monoclonal antibodies, fusion proteins, or other large molecules.
- ADC (antibody-drug conjugate) stability experience.
- Hands-on experience with stability data review, trending, and shelf-life assessment.
- Prior experience managing external CTLs, CDMOs, CROs, or stability storage vendors supporting regulated studies.
- Working knowledge of GMP requirements, data integrity expectations, and regulatory expectations for biologics stability studies.
- Working knowledge of ICH stability guidance (e.g., Q1A(R2), Q1B, Q1D, Q1E, Q5C) and FDA/EMA expectations.
- Familiarity with analytical technologies used in biologics stability testing (HPLC/UPLC, SEC, CE-SDS/cIEF/icIEF, ELISA, binding and potency assays).
- Strong project management skills to manage detailed schedules, multiple vendors, cross-functional dependencies, and competing priorities.
- Excellent documentation, communication, and stakeholder management skills; ability to operate independently in a matrixed environment.
- Prior contract or consultant experience in a matrixed biotech environment.
What We Do
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class 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-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. 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.
