Quality Control Analyst II - Molecular Biology

About the role

A pharmaceutical company in Massachusetts is seeking a Quality Control Analyst II to join their Molecular Biology team.

Responsibilities

• Perform routine QC testing including but not limited to: ddPCR, dPCR, and qPCR test methods in support of in-process, release, and stability.
• Review and approval of cGMP analytical data for release and stability testing from internal and external analytical test methods.
• Support the QC Molecular Biology laboratory operations (e.g., instrument qualification and maintenance, housekeeping, qualify critical reagents).
• Author and support quality events: Change controls, Deviation, CAPA, OOS Investigation, as needed.
• Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/validation protocols, and Method transfer/validation reports for internal and external methods.
• Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.
• Author analytical method performance trend reports, as needed.
• Work with cross-functional teams with both internal and external stakeholders.
• Perform other duties, as needed.

Requirements

• 2+ years of related industry experience.
• Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry.
• Bachelor's and/or Master's Degree in Biochemistry, Biology, Chemistry, or a related discipline.
• Hands-on experience with performing dPCR, ddPCR, and/or qPCR test method execution.
• Strong collaboration and team-working skills.
• Strong communication, interpersonal, and organizational skills.
• Ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.