Sr. Staff Development Scientist

Danaher Corporation•West Sacramento, CA

2d•$200,000 - $220,000•Onsite

About The Position

At Beckman Coulter Diagnostics, a global leader in clinical diagnostics and an operating company of Danaher, the Sr. Staff Development Scientist will lead complex antimicrobial susceptibility testing (AST) development programs. This role involves driving experimental strategy using Design of Experiments (DOE), making technical decisions across multiple projects, and collaborating cross-functionally to advance products from feasibility through regulatory clearance. The position is part of the Development Science team in West Sacramento, California, and is an on-site role reporting to the Director, R&D Assay Development, Microbiology.

Requirements

Demonstrated experience leading complex AST (antimicrobial susceptibility testing) assay-development programs or comparable regulated diagnostic product-development programs.
Demonstrated expertise in Design of Experiments (DOE) creation, advanced data analysis, and evidence-based technical decision-making.
Experience supporting the full development lifecycle from feasibility through regulatory clearance, including demonstrated 510(k) submission experience.
Experience authoring design control documentation and supporting audits, risk management, CAPA investigations, verification, and design transfer.
PhD in Microbiology, Molecular Biology, Biochemistry, or a related discipline with 9+ years of experience; OR Master’s degree with 12+ years of experience; OR Bachelor’s degree with 14+ years of experience.

Nice To Haves

Experience providing technical leadership in collaborations with CROs, vendors, universities, or other external partners.
Experience serving as a microbiology subject matter expert supporting Systems Engineering or Software integration efforts.
Experience identifying and evaluating emerging technologies and contributing to technology roadmap development.

Responsibilities

Lead 2-3 concurrent development projects or one multi-project program, establishing technical strategy, aligning major workstreams, and driving execution across Development Science.
Lead development and optimization of antimicrobial susceptibility testing (AST) assays, creating complex, statistically sound experimental designs using Design of Experiments (DOE) methodologies.
Serve as the Development Science subject matter expert, guiding programs from feasibility through regulatory clearance, including authoring and approving design control documentation.
Partner with Regulatory Affairs, Manufacturing, Clinical Affairs, Systems Engineering, Software, and Program Management to resolve complex technical issues and support audits, risk management, and CAPA investigations.
Mentor and develop scientific staff, leading technical reviews, and building training programs and knowledge-sharing tools that strengthen organizational capability.