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Remote Senior Scientist, Bioassay Development
Remote San Francisco, CA 94158 US
Job Description
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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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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