Cmc Project Manager Jobs in Bothell, WA (NOW HIRING)

Position Overview

Immunome is seeking a highly experienced and strategic Associate Director, Quality Control, Biologics to lead QC strategy and execution in support of our biologics and ADC portfolio. This role will be responsible for oversight of GMP QC activities, including analytical method transfer, qualification and validation, release and stability testing, investigation support, external testing lab management, and QC documentation supporting clinical development and regulatory submissions. 

The successful candidate will bring deep technical expertise in biologics and ADC analytical testing, a strong working knowledge of GMP requirements and global regulatory expectations, and the leadership skills necessary to manage cross-functional and external partners. This position offers a highly visible opportunity to build scalable QC processes and ensure Immunome's products are tested with scientific rigor, operational discipline, and patient-centered quality. 

Responsibilities

QC Strategy and Governance 

• Develop and implement phase-appropriate QC strategies for biologics and ADC programs across drug substance and drug product development, release, and stability. 

• Provide scientific, technical, and GMP oversight for QC testing, method lifecycle activities, specifications, reference standards and critical reagent strategies. 

• Contribute to the long-term vision for Immunome's QC capabilities, including evaluation of technologies, systems, and external partnerships to support portfolio growth. 

Program Oversight and Execution 

• Oversee execution of GMP and non-GMP analytical testing for intermediates, drug substance, drug product, and stability samples in collaboration with CTLs and CDMOs. 

• Lead review and interpretation of QC data, trends, OOS/OOT results, deviations, investigations, CAPAs, change controls, and technical reports. 

• Serve as the QC representative on cross-functional program teams, ensuring QC deliverables are aligned with CMC timelines. 

External Laboratory and Partner Management 

• Manage external contract testing laboratories and CDMO QC functions to ensure timely, compliant, and high-quality study execution. 

• Oversee method transfer, qualification, validation, verification, and troubleshooting activities across external laboratories. 

• Establish expectations for documentation quality, sample management, stability pulls, and communication cadence with external partners. 

Regulatory and Documentation Support 

• Author and review QC-related SOPs, protocols, validation and qualification plans, method transfer reports, specifications, CoAs, stability summaries, and regulatory submission content. 

• Support preparation of IND, BLA, CTD, and other global regulatory submissions, including responses to health authority questions related to QC and analytical controls. 

• Stay informed of emerging regulatory expectations and compendial requirements, integrating relevant guidance into Immunome's QC strategy. 

Leadership and Collaboration 

• Lead, mentor, and develop scientists and technical staff, fostering a high-performance culture grounded in quality, accountability, and collaboration. 

• Partner closely with Analytical Development, Process Development, Manufacturing, Quality Assurance, Regulatory CMC, Supply Chain, and Program Management to align QC plans with broader development objectives. 

• Communicate complex QC data, risks, and recommendations clearly to functional leaders and program teams, enabling timely, science-based decision-making. 

Qualifications

• A Bachelor's or advanced degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related field. 

• 10+ years of experience in Quality Control, Analytical Development, CMC, or related functions within the biotechnology or biopharmaceutical industry or equivalent; advanced degree may offset some experience. 

• Demonstrated experience supporting QC programs for biologics; ADC experience strongly preferred. 

• Proven experience with GMP release and stability testing, analytical method transfer, qualification, validation, and lifecycle management. 

• Prior experience managing CTLs, CDMOs, CROs, or other external partners supporting regulated testing. 

• Experience managing matrixed projects, or external partner relationships in a fast-paced development environment. 

Knowledge and Skills

• In-depth understanding of GMP standards, data integrity expectations, and global regulatory guidance relevant to biologics QC, analytical validation, stability, and CMC submissions. 

• Strong technical knowledge of biologics and ADC product quality attributes, including potency, purity/impurities, charge variants, glycosylation, aggregation, conjugation-related attributes, and linker-payload characteristics. 

• Working knowledge of analytical technologies such as HPLC/UPLC, CE-SDS/cIEF, icIEF, LC-MS, ELISA, binding and potency assays, compendial methods, and microbiological testing. 

• Operational and strategic experience with phase-appropriate method development, qualification, validation, method transfer, compendial verification, and stability program design. 

• Ability to assess QC data trends, deviations, OOS/OOT results, and analytical risks, translating findings into practical recommendations and CAPA plans. 

• Excellent judgment and the ability to transition seamlessly between hands-on technical review and strategic decision-making. 

• Comfortable with ambiguity and complex challenges; adapt quickly and lead teams through dynamic environments. 

• Exceptional communication skills with the ability to collaborate effectively across functions and with external partners. 

• Solution-oriented problem-solving skills, with the capacity to manage multiple projects and prioritize in a fast-paced setting.