Associate Scientist, Potency Method Development
About The Position
This role is responsible for managing and performing scientific research, development, and testing of new products, manufacturing processes, and raw materials. It contributes to the development of innovative therapies by ensuring the quality and efficiency of manufacturing processes. The Associate Scientist is adept at solving moderate scope and complexity problems, exercising judgment within established procedures, and fostering productive relationships. They possess solid knowledge of industry practices and contribute to departmental projects and goals, often engaging in frequent internal and external interactions. They may occasionally lead small project teams and provide informal guidance to junior staff, all while working with minimal guidance themselves.
Requirements
- MS in Biology, Biochemistry or related discipline with a minimum of 0-2 years relevant industry experience in product and process development.
- BS in Biology, Biochemistry or related discipline with a minimum of 1-3 years relevant industry experience.
- Experience with aseptic technique, tissue culture, multichannel pipetting, reagent preparation based on established procedures, and general laboratory upkeep and equipment maintenance.
- Ability to plan, execute, interpret, and communicate complex experimental work across two or more projects or functional priorities with limited supervision.
- Demonstrated ability to work effectively in a collaborative team environment and communicate with cross-functional partners.
- Ability and motivation to gain in-depth understanding of new technologies, method platforms, and scientific concepts.
- Experience with a variety of assays, including cell-based assays, ELISAs, flow cytometry, SPR, and/or other assays used to study function and assess potency of biologics
- Demonstrated ability to perform routine calculations related to sample preparation and method execution.
Nice To Haves
- Experience programming and operating automated liquid handling platforms such as the Hamilton Vantage preferred but not required.
Responsibilities
- Design, develop, optimize, and implement cell-based and ligand binding potency assays to support product characterization, release, stability, comparability, and lifecycle management.
- Assess assay performance, biological relevance, and suitability for intended use through phase-appropriate method qualification design and execution.
- Plan and coordinate work with departmental, cross-functional, and external stakeholders, including Process Development, Quality Control, CTOs, Analytical Sciences, Quality Assurance, and other Analytical Development teams.
- Troubleshoot complex analytical methods and identify contributors to method performance issues.
- Prepare and review technical documentation, including method development reports, technology transfer documents, standard operating procedures, and qualification or validation protocols and reports.
- Present findings internally and externally through presentations, posters, publications, invention disclosures, or patent-related contributions.
- Complete all required training and maintain high standards for safety, data integrity, GxP awareness, and documentation quality.
Benefits
- medical, dental, vision insurance
- a 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- a tuition reimbursement program
- paid volunteer time off
- company holidays
- well-being benefits
- up to 80 hours of sick time per calendar year
- up to 120 hours of paid vacation for new hires
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
