Sr. Scientist

Job Description

Job Summary:

• 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.

Duties and Responsibilities:

1. Strategic Leadership:

• Define and execute bioassay development strategies for protein, antibody therapeutics, ADCs, multispecific biologics, and other Client 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.

2. 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.

3. 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 Client Analytical Development function in cross-functional and external discussions.

Requirements:

• 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.

Additional Details:

• Type: Remote, Contract.
• Compensation: Competitive hourly rate*** commensurate with experience.
• Eligibility: Contract role, not benefits-eligible during contract period.

Schedule Hours Per Week: 40.00
Schedule Hours Per Day: 8.00
Schedule Days Per Week: 5.00