ZipRecruiter
Bioanalytic Sr Scientist, Bioassay Development (W2 Contract Role)
ZipRecruiter, Myrtle Point, Oregon, United States, 97458
Position Overview
Greetings from IT Engagements Position Overview: Client is 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, 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 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 Client 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 Cient’s Analytical Development function in cross-functional and external discussions. Qualifications
Advanced degree (PhD or MS with equivalent experience) 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.). Binding assays: ELISA, TR-FRET, Octet (BLI), etc. Experience with mammalian cell culture and bioassay development in a CMC setting. 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. Thank you Contact: vinaya@itengagements.com
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Greetings from IT Engagements Position Overview: Client is 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, 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 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 Client 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 Cient’s Analytical Development function in cross-functional and external discussions. Qualifications
Advanced degree (PhD or MS with equivalent experience) 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.). Binding assays: ELISA, TR-FRET, Octet (BLI), etc. Experience with mammalian cell culture and bioassay development in a CMC setting. 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. Thank you Contact: vinaya@itengagements.com
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