Remote Senior Scientist, Bioassay Development
OverviewJoin to apply for the Remote Senior Scientist, Bioassay Development role at Planet PharmaPosition Overview :The company is seeking a Senior Scientist to lead its 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.ResponsibilitiesStrategic LeadershipDefine and execute bioassay development strategies for protein, antibody therapeutics, ADCs, multispecific 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 OversightDirect 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 SupportOversee 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.QualificationsAdvanced degree (PhD or MS with equivalent experience) in biology, biochemistry, cell / molecular biology, or related field.10years of industry experience in bioassay development for biologics, including 3years 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.).Binding assays :ELISA, TR-FRET, Octet (BLI), etc.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.The Planet Group of Companies is an equal opportunity employer.We celebrate diversity and are committed to creating an inclusive environment for all employees.J-18808-Ljbffr. Experience: 5 years required