Senior Manager, Quality Control Analytical
$145,000–$159,500 year
On-site · Dunkirk, New York, United States
Job Summary
Senior Manager, Quality Control Analytical will oversee laboratory testing activities for programs including fusion proteins, cell therapies and cancer vaccines, encompassing in-process testing, suitability-for-use testing, method development, qualification, transfer, and investigational studies. Responsibilities include coordinating method troubleshooting, creating protocols and reports in alignment with GMP/cGMP standards, supervising QC Analytical lab staff, driving method development and transfer, ensuring regulatory compliance and data integrity, coordinating cross-functional activities, and performing assay reviews. On-site leadership in Dunkirk, NY with the ability to coordinate schedules, maintain SOPs, and support a broad range of analytical testing (HPLC, capillary electrophoresis, UV-Vis, ELISA) within a biopharmaceutical GMP framework.
Required Qualifications
- Bachelor’s degree in Cell Biology or Immunology or related discipline with 8+ years’ relevant experience in analytical development or quality control testing; OR Master’s degree in Biology or related discipline with 6+ years’ relevant experience in analytical development or quality control testing
- Experience with QC testing requirements, methodology and equipment such as HPLC and Plate Readers
- Demonstrated understanding of QC testing requirements, methodology and equipment in GMP/cGMP environments
- Knowledge of cGMP, FDA, and USP regulations and data integrity principles
- Ability to lead a team in a GMP environment
- Ability to work independently and within cross-functional teams to meet project timelines
- Proficiency with MS Word, PowerPoint, Excel
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