Senior Manager, Quality Control Analytical

Position Summary

The Senior Manager, Quality Control Analytical will be assigned responsibilities for the management of laboratory testing activities for various programs (fusion proteins, cell therapies and cancer vaccines), routine preventive maintenance, and completing lab administrative duties. The position will be responsible for providing testing support through In Process testing, suitability for use testing, method development, optimizations, transfer, qualification and investigational studies. The analytical testing includes wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA, but not limited to. The position will be required to oversee and coordinate method troubleshooting and investigations. Creating protocols and reports will also be required, using knowledge of GMP/cGMP practices to incorporate the appropriate regulatory requirements into the methods and procedures.

The position provides onsite oversight of a wide variety of complex tasks that support the establishment, transfer of the methods into the other QCA lab, and perform various investigational testings.

Essential Functions

• Oversight and scheduling of analytical testing for In Process testing, suitability for use testing, method development, qualification, optimizations, transfer and investigational studies.
• Oversight of the QC Analytical lab staff, including hiring, training functions, 1:1 meetings, and career development for QCA staff.
• Interface as QCA member to interact with other departments to coordinate activities.
• Review of assay protocols and reports in line with commercial GMP standards.
• Backup analyst for completing assays.
• Participate and coordinate method development, optimization, transfer, and qualification work (protocol drafting, data collection, and report writing).
• SOP and Test Method drafting and revisions.
• Ensure quality control staff, equipment, and procedures are compliant to regulatory guidelines and data integrity principles are adhered to.
• Performs other projects and duties as assigned.

Education & Experience

• Bachelor’s degree in Cell Biology or Immunology or related discipline with 8+ years’ of relevant experience in the biotechnology industry with emphasis in analytical development or quality control testing required; OR
• Master’s degree in Biology or related discipline with 6+ years of relevant experience in the biotechnology industry with emphasis in analytical development or quality control testing required
• Experience with QC testing requirements, methodology and equipment such as HPLC and Plate Readers required
• Experience leading a team in a GMP environment strongly preferred
• Demonstrated self and team adaptability under changing circumstances to deliver results

Knowledge, Skills, & Abilities

• Demonstrated understanding of QC testing requirements, methodology and equipment such as HPLC and Plate Readers.
• Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
• Knowledge of MS Word, PowerPoint, and Excel
• Ability to work independently and within cross-functional teams to deliver on project timelines and department goals.

Working Environment / Physical Environment

• This position works on-site in Dunkirk, NY
• This position works in a lab environment
• Flexibility in working schedule, i.e., off-hours
• Must be able to gown and gain entry to labs
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds