Senior Analyst I, Quality Control Chemistry

Overview

• Support gene therapy pipeline through technical transfer, method qualification, validation, and GMP testing of AAV vector analytical methods.
• Perform routine QC testing of in-process, drug substance, drug product, and raw material samples.
• Collaborate with Quality Control, Analytical Development, Quality Assurance, Manufacturing, and CROs teams.
• Contribute to data trending, invalid assay investigations, and quality event management.
• Execute analytical methods for product release and stability using advanced techniques.
• Support laboratory operations including instrument qualification, housekeeping, and reagent qualification.
• Prepare and present technical reports, SOPs, and validation protocols.
• Mentor and train junior staff while modeling leadership behaviors.
• Adapt responsibilities to support activities relevant to the clinical phase.

Key Responsibilities & Duties

• Perform analytical testing for AAV products using techniques like HPLC, LCMS, AUC, UV, and CE-SDS.
• Review and approve cGMP analytical data for product release and stability testing.
• Lead QC Chemistry laboratory operations, including instrument maintenance and reagent qualification.
• Author and support quality events such as change controls, deviations, CAPAs, and OOS investigations.
• Prepare technical documentation, including SOPs, validation protocols, and reports.
• Conduct method transfer and validation for internal and external laboratories.
• Collaborate with external contract labs for testing and validation activities.
• Train and mentor junior staff, fostering a collaborative and productive environment.
• Adapt to evolving responsibilities to support clinical phase activities.

Job Requirements

• Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, Biophysics, or related field.
• Minimum of 5 years of experience in a cGMP QC laboratory within the pharmaceutical or biopharmaceutical industry.
• Proficiency in analytical techniques such as HPLC, LCMS, AUC, UV-Vis, and CE-SDS.
• Experience with external contract labs (CMOs, CROs) is advantageous.
• Strong collaboration, communication, and organizational skills.
• Ability to work independently and prioritize tasks effectively in a dynamic environment.
• Motivated and skilled in multitasking with excellent technical and organizational abilities.
• Adaptable to changing priorities and clinical phase requirements.
• Demonstrated leadership and mentoring capabilities.