Sr. Staff Development Scientist

Beckman Coulter Diagnostics; West Sacramento (CA); On-site; USD 200,000 - 220,000; Full time

Benefits offered by this job

Bonus eligibility

Medical/dental/vision

401(k) plan

Job summary

Beckman Coulter Diagnostics in West Sacramento, CA, is seeking a Sr. Staff Development Scientist to lead antimicrobial susceptibility testing (AST) development programs from feasibility through regulatory clearance.

You will design complex DOE experiments, act as a subject matter expert, and partner with Regulatory Affairs, Manufacturing, Clinical Affairs, Systems Engineering, Software, and Program Management to resolve technical issues and support audits.

Qualifications

• Experience leading complex AST assay-development programs or comparable regulated diagnostic product-development programs.
• 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 related discipline with 9+ years of experience; OR Masters with 12+ years of experience; OR Bachelors with 14+ years of experience.

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.

Skills

AST development leadership

DOE design of experiments

Regulatory clearance experience

Design control documentation

Risk management & CAPA

Education

PhD in Microbiology or related field

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision makingwe are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System which makes everything possible.

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 Masters degree with 12+ years of experience; OR Bachelors 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 its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
• This job is also eligible for bonus/incentive pay.

The annual salary range for this role is $200,000-220,000.

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 Companys sole discretion, consistent with the law.

Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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