Quality Control Bioassay Consultant

Woburn, MA

Job Type: Contract

Recruiter: Hillary Bergstrom (https://digitalprospectors.com/our-team/hillary-bergstrom)

Phone: 603-772-2700

Position: Quality Control Consultant (Bioassay)

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.

Qualifications:

• 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.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

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.

Come see why DPC has achieved:

• 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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