Associate Director, Quality Control, Biologics
Immunome, Inc.
July 02, 2026
Remote friendly (Bothell, WA)
United States
Operations
Associate Director, Quality Control, Biologics
Responsibilities
- Develop and implement phase-appropriate QC strategies for biologics/ADCs across drug substance/product development, release, and stability.
- Provide scientific/technical/GMP oversight for QC testing, method lifecycle, specifications, reference standards, and critical reagents.
- Oversee GMP and non-GMP analytical testing for intermediates, drug substance/product, and stability samples with CTLs and CDMOs.
- Review/interprete QC data, trends, OOS/OOT results, deviations, investigations, CAPAs, change controls, and technical reports.
- Serve as QC representative on cross-functional program teams to align QC deliverables with CMC timelines.
- Manage external testing labs/CDMO QC; oversee method transfer, qualification, validation, verification, and troubleshooting.
- Author/review QC SOPs, protocols, validation/qualification plans, method transfer reports, specifications, CoAs, stability summaries, and regulatory submission content.
- Support IND/BLA/CTD submissions and responses to health authority questions related to QC/analytical controls.
- Lead, mentor, and develop staff; partner with internal functions to align QC plans with development objectives.
Qualifications
- BS or advanced degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related field.
- 10+ years in QC/Analytical Development/CMC (advanced degree may offset); biologics QC experience required; ADC experience strongly preferred.
- Proven experience with GMP release and stability testing; method transfer, qualification, validation, and lifecycle management.
- Experience managing CTLs/CDMOs/CROs and regulated external partners.
- Ability to manage matrixed projects in fast-paced environments.
Knowledge/Skills
- Strong GMP, data integrity, and global regulatory knowledge.
- Expertise in biologics/ADC quality attributes (e.g., potency, purity/impurities, charge variants, glycosylation, aggregation, conjugation/linker-payload attributes).
- Working knowledge of HPLC/UPLC, CE-SDS/cIEF, icIEF, LC-MS, ELISA, binding/potency assays, compendial and microbiological testing.
Pay Range: $177,813 - $203,985 USD
Responsibilities
- Develop and implement phase-appropriate QC strategies for biologics/ADCs across drug substance/product development, release, and stability.
- Provide scientific/technical/GMP oversight for QC testing, method lifecycle, specifications, reference standards, and critical reagents.
- Oversee GMP and non-GMP analytical testing for intermediates, drug substance/product, and stability samples with CTLs and CDMOs.
- Review/interprete QC data, trends, OOS/OOT results, deviations, investigations, CAPAs, change controls, and technical reports.
- Serve as QC representative on cross-functional program teams to align QC deliverables with CMC timelines.
- Manage external testing labs/CDMO QC; oversee method transfer, qualification, validation, verification, and troubleshooting.
- Author/review QC SOPs, protocols, validation/qualification plans, method transfer reports, specifications, CoAs, stability summaries, and regulatory submission content.
- Support IND/BLA/CTD submissions and responses to health authority questions related to QC/analytical controls.
- Lead, mentor, and develop staff; partner with internal functions to align QC plans with development objectives.
Qualifications
- BS or advanced degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related field.
- 10+ years in QC/Analytical Development/CMC (advanced degree may offset); biologics QC experience required; ADC experience strongly preferred.
- Proven experience with GMP release and stability testing; method transfer, qualification, validation, and lifecycle management.
- Experience managing CTLs/CDMOs/CROs and regulated external partners.
- Ability to manage matrixed projects in fast-paced environments.
Knowledge/Skills
- Strong GMP, data integrity, and global regulatory knowledge.
- Expertise in biologics/ADC quality attributes (e.g., potency, purity/impurities, charge variants, glycosylation, aggregation, conjugation/linker-payload attributes).
- Working knowledge of HPLC/UPLC, CE-SDS/cIEF, icIEF, LC-MS, ELISA, binding/potency assays, compendial and microbiological testing.
Pay Range: $177,813 - $203,985 USD