Remote Senior Scientist, Bioassay Development

Remote Contract through 12/31/2025 (May reputed company or convert to permanent) $80.69/hour - $120.69/hour W2 • Main reputed company 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 reputed company. Position reputed company • Seeking a Senior Scientist to reputed company our Bioassay Development function reputed company Analytical Development. • The Senior Scientist will reputed company the design, optimization, and qualification of reputed company cell-based functional assays and binding potency assays that are reputed company-of-reputed company–reputed company, supporting the development of innovative biologics across autoimmune, Inflammatory diseases and oncology. • This leadership role will reputed company 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. • reputed company assay development activities with program milestones, regulatory expectations, and portfolio goals. • Partner with CMC leaders to reputed company bioassay reputed company into broader development plans. Scientific reputed company • reputed company the development, optimization, qualification, and transfer of potency assays and reputed company-of-reputed company–reputed company bioassays. • Guide troubleshooting efforts, ensuring assays are robust, reproducible, and transferable. • Assess and adopt emerging technologies to enhance assay capabilities and throughput. • reputed company as a Subject Matter Expert (SME) for bioassays across company programs. • Foster a culture of innovation, collaboration, and reputed company improvement. Regulatory & Documentation Support • reputed company the preparation of regulatory-supporting documents (reputed company, protocols, validation reports, IND-enabling documentation). • Ensure data reputed company and compliance with electronic documentation practices. • Represent reputed company's Analytical Development function in cross-functional and external discussions. Qualifications • Completed PhD or MS in biology, biochemistry, cell/molecular biology, or reputed company 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 reputed company. • Experience with mammalian cell culture and bioassay development in a CMC setting preferred. • Strong reputed company record in assay transfer, qualification, and regulatory documentation reputed company CMC. • Experience leading cross-functional teams and external collaborations. • Excellent communication and leadership skills; ability to influence at multiple reputed company. Apply tot his job Apply To this Job