QC Project Manager- BLA Capillary Electrophoresis
3 weeks ago
QC Project Manager- BLA Capillary Electrophoresis QC Project Manager- BLA Filing- Princeton NJ General Description The ideal candidate must have experience supporting regulatory submission readiness, with a strong focus on tracking QC deliverables, testing schedules, and resource loading to ensure all activities align with the Client's July 2026 BLA filing commitment. This role is responsible for establishing QC programs and ensuring GMP-compliant testing and release of materials, intermediates, and finished products under FDA, EU, and international regulations. The candidate will lead laboratory investigations (OOS, OOT, OOE), support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission. Essential Functions Utilize project management tools to track QC testing deliverables, ensuring execution aligns with the July 2026 BLA submission timeline. Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones. Support preparation and review of technical reports and QC documentation required for the BLA, ensuring timely completion and regulatory accuracy. Create, maintain, and monitor QC testing trackers, documenting tests, timelines, assigned analysts, sample workflows, and status updates. Facilitate and maintain a resource loading tracker, aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA. Author technical documents including SOPs, test methods, method validation protocols/reports, and material specifications. Lead investigations for OOS, OOT, OOE results, ensuring thorough root-cause analysis and compliant documentation. Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission. Lead the establishment and maintenance of a stability program, ensuring data availability for regulatory filing. Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations. Perform additional duties as required to support QC, compliance, and BLA submission needs. Core Competencies, Knowledge & Skill Requirements Bachelor's degree in Chemistry, Biochemistry, Biotechnology, or related scientific discipline. 712 years of experience in an FDA-regulated pharmaceutical or biotechnology environment, with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA). Proficiency with analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation. Strong working knowledge of USP/EP, cGMP, EU GMP, and analytical compliance requirements. Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments. Proven experience tracking testing deliverables, coordinating QC schedules, and supporting regulatory timelines. Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.
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Princeton, United States Kelly Services, Inc. Full time> QC Project Manager- BLA Filing- Princeton NJ General Description The ideal candidate must have experience supporting regulatory submission readiness, with a strong focus on tracking QC deliverables, testing schedules, and resource loading to ensure Project Manager, QC, Manager, Chemistry, Regulatory, Support, Business Services, Staffing
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Senior Analyst QC Chemistry
2 days ago
Pennington, NJ, United States ClinLab Solutions Group Full timeSenior Analyst, QC Chemistry – Hopewell, NJ General Description: Perform QC Chemistry laboratory activities with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International...
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Princeton, United States Summit Therapeutics, Inc. Full timeAssociate Director, CMC/Quality Project Management (Biologics) The pay range for this role is $153,000-$180,000 annually. About Summit Ivonescimab, known as SMT112, is a novel, potential first?in?class investigational bispecific antibody combining the effects of immunotherapy via PD?1 blockade with the anti?angiogenesis effects of VEGF inhibition. It...
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Princeton, United States Summit Therapeutics Sub, Inc. Full timeCareer Opportunities with Summit Therapeutics Sub, Inc.A great place to work.Careers At Summit Therapeutics Sub, Inc.Current job opportunities are posted here as they become available.Associate Director, CMC/Quality Project Management (Biologics)Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining...
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Senior CMC Project Manager
2 days ago
Princeton, United States Summit Therapeutics Sub, Inc. Full timeCareer Opportunities with Summit Therapeutics Sub, Inc.A great place to work.Careers At Summit Therapeutics Sub, Inc.Current job opportunities are posted here as they become available.Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the...
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Senior Manager, Regulatory Project Manager
3 weeks ago
Princeton, United States Ascendis Pharma Full timeRegulatory Project Manager Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues....
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Princeton, NJ, United States Hengrui Pharma Full timeWe are seeking a highly experienced and strategic scientific leader to serve as the Head of Analytical Science, Biologics . This individual will oversee all aspects of analytical method development, qualification/validation, transfer, and quality control testing for biologics—including monoclonal antibodies, therapeutic proteins, antibody drug conjugates,...
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Princeton, NJ, United States Hengrui Pharma Full timeWe are seeking a highly experienced and strategic scientific leader to serve as the Head of Analytical Science, Biologics . This individual will oversee all aspects of analytical method development, qualification/validation, transfer, and quality control testing for biologics—including monoclonal antibodies, therapeutic proteins, antibody drug...
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Senior Manager, Regulatory Project Manager
2 days ago
Princeton, United States Ascendis Pharma AS Full timeAscendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of...
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Senior Project Manager
4 weeks ago
Princeton, United States Project Management Institute Full timeDepartment Dean for Research, Office of Category Research and Laboratory Job Type Full-Time Overview The Senior Project Manager will manage and coordinate the end-to-end execution of the contract renewal process for the contract between Princeton University and the US Department of Energy for the management and operations (the "M&O contract") of the...
