Senior Research Associate, Potency Method Development
Takeda
Summary
Join Takeda as a Senior Research Associate, Potency Method Development, responsible for managing and performing scientific research, development, and testing of new products, manufacturing processes, and raw materials. Reporting to the Head of the Cell-Based Potency Assay Development team within Analytical Development, Biologics, you will design, develop, qualify, and transfer cell-based and ligand binding potency assays and related analytical methods for biologics programs. This is a hands-on, laboratory-based position with no direct people management responsibilities.
Job description
How you will contribute
- Design, develop, optimize, and implement cell-based and ligand binding potency assays to support product characterization, release, stability, comparability, and lifecycle management.
- Evaluate assay performance, biological relevance, and fitness for purpose through the design and execution of phase-appropriate method qualification studies.
- Collaborate with cross-functional teams including Process Development, Quality Control, Quality Assurance, Analytical Sciences, Contract Testing Organizations (CTOs), and other Analytical Development partners to advance project goals.
- Troubleshoot complex analytical methods and identify factors affecting assay performance, reliability, and reproducibility.
- Author and review technical documentation including development reports, technology transfer packages, standard operating procedures (SOPs), and qualification or validation protocols and reports.
- Communicate scientific findings through presentations, publications, posters, invention disclosures, and patent-related contributions as appropriate.
- Maintain compliance with applicable quality standards, safety requirements, data integrity expectations, and documentation practices.
What you bring to Takeda
- MS in Biology, Biochemistry, or a related scientific discipline with 0-2 years of relevant industry experience in product or process development; or BS in Biology, Biochemistry, or a related scientific discipline with 1-3 years of relevant industry experience.
- Experience with aseptic techniques, mammalian cell culture, multichannel pipetting, reagent preparation, and general laboratory operations and equipment maintenance.
- Ability to independently plan, execute, analyze, and communicate complex experimental studies across multiple projects with limited supervision.
- Strong collaboration and communication skills with the ability to work effectively across cross-functional teams.
- Demonstrated scientific curiosity and the ability to quickly learn new technologies, analytical platforms, and scientific concepts.
- Hands-on experience with potency and functional assays, including cell-based assays, ELISA, flow cytometry, SPR, and related analytical techniques used to assess biologic products.
- Ability to perform routine laboratory calculations associated with sample preparation and method execution.
- Experience programming and operating automated liquid handling systems such as the Hamilton Vantage.
Requirements
- MS in Biology, Biochemistry, or a related scientific discipline with 0-2 years of relevant industry experience in product or process development; or BS in Biology, Biochemistry, or a related scientific discipline with 1-3 years of relevant industry experience
- Experience with aseptic techniques, mammalian cell culture, multichannel pipetting, reagent preparation, and general laboratory operations and equipment maintenance
- Ability to independently plan, execute, analyze, and communicate complex experimental studies across multiple projects with limited supervision
- Strong collaboration and communication skills with the ability to work effectively across cross-functional teams
- Demonstrated scientific curiosity and the ability to quickly learn new technologies, analytical platforms, and scientific concepts
- Hands-on experience with potency and functional assays, including cell-based assays, ELISA, flow cytometry, SPR, and related analytical techniques used to assess biologic products
- Ability to perform routine laboratory calculations associated with sample preparation and method execution
- Experience programming and operating automated liquid handling systems such as the Hamilton Vantage
Benefits
- Base Salary Range $89,900 - $141,240
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.