Overview In this role you lead cell-based potency assay development and lifecycle management for biologics, acting as a technical leader across programs. You translate mechanism of action insights into robust analytical methods that support GMP release, stability, comparability, and regulatory submissions. You will mentor junior staff and collaborate with cross-functional teams while driving strategy and innovation in potency assays. This opportunity appeals to researchers who shape analytical development and ensure scientific excellence at Takeda.
Compensation / Benefits- base salary with incentives
- medical, dental, vision insurance
- 401(k) with company match
- tuition reimbursement
- paid volunteer time off
- paid vacation and holidays
Responsibilities- Lead design, execution, and reporting of potency assay development, qualification, validation, and lifecycle management studies
- Develop and implement cell-based potency assays and functional bioassays for product characterization and lifecycle management
- Translate mechanism of action insights into assay formats and connect to analytical control strategy
- Provide technical leadership for assay development workstreams, programs, and initiatives
- Represent Analytical Development in cross-functional teams, communicating strategy, risks, and resource needs
- Lead statistical analyses for potency assays, including dose-response modeling and acceptance criteria
- Plan and coordinate work withProcess Development, Quality Control, contract labs, Regulatory, and other teams
- Troubleshoot complex assay, cell culture, data analysis, and transfer issues across functions
- Lead internal and external assay transfer activities, including documentation and vendor interactions
- Prepare and review technical documentation, SOPs, reports, and regulatory-ready materials
- Identify and implement improved data collection, analysis, visualization, automation, and reporting methods
- Track and apply developments in bioassay, statistics, and regulatory areas within the department
- Mentor scientists and interns, provide training, and present results internally and externally
- Complete required training and maintain high standards for safety, data integrity, GxP, and documentation quality
Key requirements- Ph.D. in a relevant field with 3+ years (Senior) or 7+ years (Principal); MS with 9+ years (Senior) or 13+ years (Principal); BS with 11+ years (Senior) or 15+ years (Principal)
- Advanced expertise in cell-based potency assay development and functional bioassays
- Advanced expertise in statistical analysis of bioassays (dose-response modeling, relative potency, curve fitting)
- Strong mammalian cell culture expertise and assay readiness
- Proficiency with readouts such as luminescence, fluorescence, ELISA, MSD, flow cytometry, and related functional readouts
- Solid knowledge of assay qualification/validation (accuracy, precision, specificity, linearity, robustness) and lifecycle readiness
- Understanding of cGMP, data integrity, ELN/LIMS documentation, SOPs, and regulatory expectations for potency assays
- Ability to lead complex workstreams with minimal supervision
- Experience with CROs/vendors for method development, transfer, validation, or lifecycle management
- Strong communication and presentation skills to diverse stakeholders
- Mentoring ability for junior staff and cross-functional teams
- Ability to work independently in a multidisciplinary setting and adapt to AI-enabled processes
- strong problem-solving
- excellent written and verbal communication
- mentoring and training
- mammalian cell culture
- potency assay development
- statistical analysis of bioassays
