Quality Control Bioassay Specialist
4 weeks ago
We are seeking a highly skilled Quality Control Bioassay Consultant to support our client's dynamic team. This role offers an exciting opportunity to contribute to cutting-edge AAV-based gene therapy programs within a GMP-compliant environment.
Key Responsibilities:
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.
Requirements:
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.
About Us:
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.
We are committed to fostering diversity, equity, and inclusion in the workplace and encourage applicants from diverse backgrounds to apply.
What We Offer:
Competitive compensation and benefits package.
Opportunities for professional growth and development.
Collaborative and dynamic work environment.
Recognition and rewards for outstanding performance.
How to Apply:
Interested candidates should submit their resume and cover letter to us today.
We look forward to hearing from you
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