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QC Analyst

Woburn, MA 01813

Posted: 10/08/2024 Employment Type: Contract Job Category: Scientific Job Number: 4052

Job Description

The Senior QC Analyst will work with others in Quality Control and Analytical Development in a dynamic environment to support AAV-based gene therapy programs.  The Senior QC Analyst will perform cell-based bioassays, ELISAs, and other biological methods in a GMP setting. In addition, the Senior QC Analyst will review, enter and approve data from external laboratories. Routine work includes release and stability testing, critical reagent qualification, method validation and transfer, critical reagent qualification, analyzing data, and authoring technical documents.

Responsibilities:
    • Performing routine QC testing including, but not limited to, quantitative PCR and cell-based assays in a GMP environment to support product release and stability.
    • Review and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms.
    • Supports and leads QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc).
    • Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
    • 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.
    • Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).
    • Model leadership behaviors and mentor/train junior staff 
    • Work with cross functional teams with both internal and external stakeholders
Requirements / Qualifications:
    • BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 5+ years industry experience
    • Experience in a GMP/GLP environment is a must.
    • Experience in routine mammalian cell culture required
    • Experience with quantitative PCR required.  Experience with cell-based potency assays is required. Experience performing immunoassays such as ELISAs strongly desired
    • Experience with statistical analysis (SoftMax, JMP) preferred
    • Ability and desire to work in a fast-paced environment
    • Strong collaboration, team-working skills, and communication skills
    • Independently motivated and detail-oriented with good problem-solving ability
    • Strong communication, interpersonal and organizational skills
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About Woburn, MA

Ready to embark on a new career adventure? Explore our job opportunities in the vibrant area around Woburn, Massachusetts! Nestled in Middlesex County, 'Woburn, the Beautiful Land' as it translates, offers job seekers a mix of urban excitement and suburban charm. With close proximity to Boston’s bustling city life and historical landmarks like the Minute Man National Historical Park, as well as delightful local cuisines including Woburn's signature roast beef sandwiches, this area promises not just a job but a lifestyle. Attend performances at The New Repertory Theatre or catch a game at the TD Garden supporting the region's beloved sports teams. Take a stroll in Horn Pond Recreation Area or immerse yourself in art at the Whistler House Museum of Art in nearby Lowell. Join us in pursuing your career in this dynamic region; your next big opportunity awaits!