Lead Scientist, Molecular & Cellular Biology
On-site · Kansas City, Missouri, United States
Job Summary
Lead Scientist, Molecular & Cellular Biology role focused on end-to-end assay development, design, and validation for Biopharma product development under cGMP. Responsibilities include leading assay generation and validation using mammalian cell culture, ELISA, molecule biology, flow cytometry, and binding assays (SPR/BLI); drafting and approving SOPs, validation protocols, and reports; serving as SME across multiple techniques; mentoring peers on cGMP compliance; ensuring thorough, compliant documentation and coordinating peer reviews; and supporting project execution from scope design to lifecycle tracking. Requires advanced degree with substantial relevant experience in relevant techniques and a strong background in GMP-regulated biopharma environments. This on-site role is based in Kansas City, MO, and offers a pathway to contribute to development programs and manufacturing support across global sites.
Required Qualifications
- Bachelor’s Degree in Life Sciences or Physical Science with minimum 11 years relevant experience, OR Master’s degree with minimum 9 years relevant experience, OR Doctorate degree with minimum 5 years relevant experience in department specific techniques
- Experience and knowledge in cGMP compliance and regulatory guidance for Biopharma product development
- Expertise in mammalian cell culture, ELISA, molecular biology, flow cytometry, binding assays (SPR/BLI) and related laboratory techniques
- Ability to draft, review, and approve SOPs, methods, validation protocols, and reports
- Mentoring, coaching, and training peers on cGMP compliance and laboratory instrumentation
- Strong documentation skills and ability to coordinate peer reviews of notebooks, reports, and protocols
- Support for project execution, proposal design, and lifecycle tracking of assays
- Bachelor’s/Master’s/Doctorate in Life Sciences or related field with progressive experience in assay development
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