Manager at Thermo Fisher Scientific in Carlsbad, CA

📌 Carlsbad 🏷️ Other 🕑 2021-07-24
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Sr. R&D Manager

The Senior R&D Manager is responsible for leading the development of a next generation IVD sequencing in vitro diagnostic assays based on Ion Torrent technology. The Senior R&D Manager leads, directs and mentors a team of R&D personnel, allocating resources as required. Will act as the technical expert and company spokesperson on new product development teams and scientific projects. The position reports to the CDx R&D Director and will work closely with the Product Management team. Responsibilities/Major duties: Develop next generation IVD sequencing-based assays following the Decision to Investigate through Product Commercialization Process (PCP) to Product Release Checkpoint, including involvement in clinical trial planning, site training, and data reviews for necessary regulatory submissions. Independently plan, direct and execute product development strategies to meet FDA (510(k) and PMA), CE-IVD, and other regulatory agency requirements. Anticipate potential problems and design preventative solutions. Determine strategic approach to experimental design. Critically analyze complex data, interpret and integrate experiment results with project and division objectives. Sets project directives based on data analysis. Maintain complete and thorough documentation required to meet QSR Design Control, as well as other international standards (e.g., ISO compliance, GLP/GMP requirements, IVD-R, etc.).Drive the documentation necessary for our programs to meet CE-IVDR requirements.
Oversee and manage R&D staff, including hiring, performance management, training and professional development. Provide strategic direction and guidance to Scientists, Research Associates and Engineers in their daily experiments and troubleshooting. Lead team in systematic problem analysis and resolution processes for project advancement. Guide team in matrix environment. Interface with other departments (i.e., Marketing, Business Development, Regulatory, Technical Service and/or Operations) to coordinate product development and improvement. Comply with all company safety regulations and procedures. Ensure compliance of assigned staff. May be required to perform other related duties as required and/or assigned.

Required Skills

Proven track record in developing IVD products, with a focus on molecular assays and systems.
Experience interacting with the CE-IVDR process.
Experience in assessing the scientific talent of a team, re-design roles as needed, and develop and recruit scientific talent.
Demonstrated ability to collaborate with and influence colleagues on cross-functional business teams.
Strong documentation skills.
Influential communicator.
Strategic and analytical skill sets.
Knowledge of diagnostic market trends.
Persistent and flexible in response to change.
Education and background: PhD in Biology, Chemistry, Biochemistry or related discipline, or the equivalent education and experience are required Minimum 6 years at Manager of R&D in diagnostics or similar regulated industrial markets. Prior demonstrated success leading teams of at least 5 people.

View Application

You will be redirected to Thermo Fisher Scientific's preferred application process.

You will be redirected to Thermo Fisher Scientific's preferred application process.

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