At the Digital Biology Group (a division of Bio-Rad) we use microfluidic chips to generate nanoliter-sized droplets as reaction vessels to power a extremely precise digital nucleic acid measurement method known as droplet digital PCR (ddPCR). As we’ve established our market lead in digital PCR, we’re expanding into new applications for our core technology. We believe our partition technology (creating hundreds of thousands of droplets) will open up new avenues in basic life sciences research and become a new paradigm in life science research and clinical diagnostics markets. We are looking for an experienced candidate to be the R&D Program Lead for the Digital Biology Group’s efforts to expand into the Non-Invasive Prenatal Testing (NIPT) IVD market.
We are looking for an exceptional candidate passionate about improving patients’ lives, who will be responsible for building and leading a high performance NIPT product development team of direct reports focused on assay development. The successful candidate will be the R&D Lead of the NIPT IVD program and have overall technical responsibility for all aspects of the program. Overall, an individual who thrives in taking and owning novel ideas from white board to full product release in a multi-disciplinary environment.
- Build, manage and lead the NIPT assay development team of direct reports ranging from Sr. Staff Scientists to Research Associates, including the coaching and mentoring of staff to ensure continuous technical and career development.
- Being a Technical Lead of the NIPT IVD program responsible for building a program team comprised of direct reports and matrixed R&D functions encompassing Microfluidic, Firmware, Software and System Engineers, Computational Biologists, and Biostatisticians. Partnering closely with Business Development, Marketing, QA, RA and PMO supporting program objectives.
- As Technical Lead, ensure all technical aspects of timely program delivery. These responsibilities include but not limited to technical decisions within the project; technical delivery of project objectives; communicating technical status of project; contributing to budget management; and compliance with quality and regulatory standards.
- In close collaboration with Marketing, invent and establish concept/feasibility of NIPT IVD products. Also collaborate with Marketing and Operations to develop the physical product specifications and configurations that deliver the optimum product performance.
- Working with the leadership team at the DBG, this individual will also be responsible for all aspects of successful application development (assay, software & system) for NIPT from product inception through development, transfer to operations, verification, clinical trial support and product launch guaranteeing high-quality IVD product delivery.
- Be a Thought Leader in NIPT clinical applications and gain a presence in the field through inventions, product commercialization, presentations and publications.
- PhD in Molecular Biology, Biochemistry, or Chemistry with 10+ years of industrial experience highlighted with successful NPIs in RUO and/or clinical markets with 5+ years of direct management experience.
- At least 10+ years of increasing responsibility in R & D technical leadership roles at a life science/diagnostics tool provider.
- Relevant experience would include NGS-tool providers (reagents and/or instruments) and/or a genomics company with NGS products in diagnostics, NIPT, consumer genomics, liquid biopsy-focused company.
- 2+ years preferred of direct NIPT product development experience with expertise in developing highly multiplexed PCR assays.
- Extensive experience in product development, with a clear understanding of Product Development Process and QMS processes punctuated with successful product launches.
- Proven track record and evidence of the ability to translate knowledge into practical achievements.
- Experience working closely with bioinformaticians and biostatisticians, NGS assay design experience an advantage.
- Detailed working knowledge of modern sequencing methods, the field of genomics, and informatics.
- Demonstrated understanding of all “wet lab” elements in and around NGS, including sample and target prep, amplification and sequencing biochemistries, polymerase enzymology,
- Proven track record in leading matrix teams, across projects and departments.
- Proven capacity to thrive in a multidisciplinary settings while leading and working alongside engineers, biologists, software developers, clinicians and manufacturing professionals.
- Clinical/diagnostic laboratory experience desirable.
- Knowledge and experience of regulated quality processes (e.g. design control) and completion of design-history files also desirable.
- Leveraging highly developed interpersonal skills to build & maintain positive working relationships with functional groups throughout the breadth of Bio-Rad’s organization.
- Excellent verbal and written communication skills, logical and analytical thinking, ability to multitask, work independently and on a team, and the ability to learn, troubleshoot, and problem solve are essential.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.