Job Description
- Position Overview
Thos company 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 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
- 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 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.
Job Tags
Remote job, Contract work,