Remote Senior Scientist, Bioassay Development
Remote Contract through 12/31/2025 (May extend or convert to permanent) $80.69/hour - $120.69/hour W2 • Main focus in analytical development on a CMC team with cell based and binding assay background and biologics. • Candidates need to have strong technical skills in CMC, cell based and binding assays and biologics. • Protein and antibody experience required as well. Position Overview • Seeking a Senior Scientist to lead our Bioassay Development function within Analytical Development. • The Senior Scientist will oversee the design, optimization, and qualification of complex cell-based functional assays and binding potency assays that are Mechanism-of-Action–reflective, supporting the development of innovative biologics across autoimmune, Inflammatory diseases and oncology. • This leadership role will provide scientific direction, ensure regulatory-compliant analytical strategies, and drive cross-functional alignment across Discovery, CMC, QC, and external partners. Key Responsibilities Strategic Leadership • Define and execute bioassay development strategies for protein, antibody therapeutics, ADCs, multi-specific biologics, and other novel modalities. • Align assay development activities with program milestones, regulatory expectations, and portfolio goals. • Partner with CMC leaders to integrate bioassay strategy into broader development plans. Scientific Oversight • Direct the development, optimization, qualification, and transfer of potency assays and Mechanism-of-Action–reflective bioassays. • Guide troubleshooting efforts, ensuring assays are robust, reproducible, and transferable. • Assess and adopt emerging technologies to enhance assay capabilities and throughput. • Act as a Subject Matter Expert (SME) for bioassays across company programs. • Foster a culture of innovation, collaboration, and continuous improvement. Regulatory & Documentation Support • Oversee the preparation of regulatory-supporting documents (methods, protocols, validation reports, IND-enabling documentation). • Ensure data integrity and compliance with electronic documentation practices. • Represent the company's Analytical Development function in cross-functional and external discussions. Qualifications • Completed PhD or MS in biology, biochemistry, cell/molecular biology, or related field. • 10+ years industry experience in bioassay development for biologics, including 3+ years in leadership or management. • Demonstrated expertise in bioassay platforms, including Cell-based assays: cytotoxicity, reporter gene, proliferation, primary cell assays, effector function assays (ADCC, CDC, etc.); and Binding assays: ELISA, TR-FRET, Octet (BLI), etc. • Protein and antibody experience required as well. • Experience with mammalian cell culture and bioassay development in a CMC setting preferred. • Strong track record in assay transfer, qualification, and regulatory documentation within CMC. • Experience leading cross-functional teams and external collaborations. • Excellent communication and leadership skills; ability to influence at multiple levels. Apply tot his job