Quality Control Bioassay Consultant
Woburn, MA
Job Type: Contract | Recruiter: Hillary Bergstrom | Phone: 603-772-2700
Location: Woburn, MA (Onsite)
Length: 6 months
Job Description:
Our client is seeking a Quality Control Bioassay Consultant to join their dynamic team. This position offers an exciting opportunity to contribute to cutting-edge AAV-based gene therapy programs within a GMP-compliant environment. As a pivotal member of their team, you will support various routine activities, including release and stability testing, reagent preparation, and data integrity reviews. If you have a strong background in bioassay methods, mammalian cell culture, and GMP practices, we invite you to bring your expertise and apply today!
Essential Duties and Responsibilities (but not limited to):
- Evaluate and approve cGMP analytical data for release and stability testing using bioassay test methods such as mRNA expression, functional potency, and ELISA testing platforms.
- Perform data integrity reviews (data verification) to support validation, qualification, and analytical method trending reports as needed.
- Support routine Laboratory Operations including, but not limited to:
- Review logbooks for reagent preparation, equipment, and critical reagent tracking.
- Conduct weekly laboratory housekeeping walkthroughs.
- Prepare reagents and perform cell passaging.
- Author and support quality events including change controls, deviations, CAPAs, and OOS Investigations as required.
- Author analytical method performance trend reports and other technical documents as needed.
- Bachelor’s degree in Cell Biology, Molecular Biology, Biochemistry, or a related discipline.
- Minimum of 5 years of industry experience in a similar role.
- Proven experience in mammalian cell culture and biological methods, including immunoassays, cell-based assays, and quantitative PCR.
- Familiarity with GMP and GLP environments is essential.
- Experience with statistical analysis software (i.e., SoftMax or JMP) is preferred.
- Ability and enthusiasm to work in a fast-paced environment.
- Strong collaboration, teamwork, and communication skills.
- Independently motivated, detail-oriented, and adept at problem-solving.
- Excellent interpersonal and organizational skills.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
- Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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