Job Description

Scientist, Microbiology – Cell & Gene Therapy

As a Microbiology Scientist, you will play a vital role on our client's growing R&D team, focused on the development and validation of assays used to characterize cell and gene therapy products. Your expertise will be essential in designing, optimizing, and troubleshooting microbiological assays, ensuring our methods meet the highest scientific and quality standards.

Key Responsibilities

• Develop, optimize, and validate microbiology assays, including endotoxin, bioburden, and sterility, for use in cell and gene therapy product characterization.
• Conduct feasibility studies and perform data analysis to support assay development.
• Author detailed protocols and validation plans to evaluate assay precision, accuracy, and linearity.
• Transfer qualified assays to the operations team for routine GMP testing.
• Collaborate cross-functionally to support both departmental and company-wide goals.

Qualifications

Education

• Master's or PhD in Microbiology (preferred).

Experience

• Minimum of 2 years of hands-on experience in developing microbiology assays from the ground up, including feasibility assessment and method validation.

Skills & Competencies

• Strong troubleshooting skills and ability to work independently in a fast-paced environment.
• Solid understanding of USP, ISO, cGMP, and FDA regulatory guidelines (preferred).
• Excellent verbal and written communication skills.
• Proactive, self-driven approach to problem-solving and continuous improvement.

Compensation & Benefits

• Scientist II: $95,000 – $100,000
• Scientist I: $85,000 – $90,000

Our client offers a competitive benefits package, performance-based bonuses, and opportunities for professional development through training programs and conferences. Relocation assistance may be offered on a case-by-case basis.

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