The Sr. Staff Development Scientist is responsible for leading complex antimicrobial susceptibility testing (AST) development programs, driving DOE-based experimental strategy and technical decision-making across multiple development projects, and partnering cross-functionally to advance products from feasibility through regulatory clearance.
This position reports to the Director, R&D Assay Development, Microbiology and is part of the Development Science team located in West Sacramento, California and will be an on-site role.
In this role, you will have the opportunity to:- 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.
The essential requirements of the job include:- 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.
Travel, Motor Vehicle Record & Physical/Environment Requirements:- Ability to travel occasionally (estimated less than 10%) to support in-person collaboration with CROs, vendors, universities, or other external development partners, as needed.
It would be a plus if you also possess previous experience in:- 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.
Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $200,000-220,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
