Potency Assay Scientist Group Leader

About the position

This role is for an advanced personnel who has in-depth knowledge of cell based and potency assays and are comfortable with troubleshooting. The Group Leader’s main technical responsibility will be to serve as SME for mRNA and gRNA potency assays to support several client programs.

Responsibilities

• Optimize, technical transfer, qualification, and validation of potency assays used for lot release and characterization of cell and gene therapy products and critical materials.
• Acting as an SME resource for potency assays.
• Execution of complex GMP release and stability assays such as cell-based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS assays.
• Author and review SOPs and technical reports.
• Work with cross-functional groups within the client environment to participate in various aspects of method development, transfer, process, and product characterization, comparability, and investigations.
• Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.
• Supports and monitors the performance of the team of employees.
• May participate in new hire interviews.
• Supports the on-boarding process of new employees.
• Disseminate administrative communications.
• Demonstrate and promote the company's vision.
• Ensure adherence to highest quality and efficiency standards in laboratory operations.
• Ensure coverage and performance for all shifts, and work duties.
• Performs administrative tasks for team member growth and development.
• Adeptly balance technical lab work with leadership responsibilities.
• Foster morale and teamwork.

Requirements

• Bachelor’s degree with 3-8 years of experience or Master’s degree with 2-5 years of experience.
• Must have experience with potency assay execution.
• Must have previous experience working in a GMP laboratory.
• Understanding of industry practices and standards is required.
• Laboratory supervisory experience is preferred.
• Team player with excellent oral and written communication skills.
• Independently motivated, detail-oriented, and excellent problem-solving abilities.

Nice-to-haves

• Strong background in cell culture and experience working with cell lines and primary human cells.
• Experience with functional, or potency assay transfer and execution in a GMP laboratory.
• Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, flow cytometry, ELISA, and NGS.
• Experience using data analysis software including JMP.
• Knowledge of ICH/USP guidelines.

Benefits

• Comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.