Sr Manager, Molecular Biology

Organization
Thermo Fisher Scientific
Job Location
South San Francisco, CA
Job Description

The Senior Manager, Molecular Biology will work closely with cross-functional leads to support the product development process within Genetic Sciences Divisional R&D, South San Francisco. The day-to-day duties will include line management of Scientists and Engineers responsible for verification and validation activities relating to new product development, ranging from molecular assays to instrumentation and full application workflows. Furthermore, the position will entail project leadership responsibilities and cross-functional project management for the development of new products as well as sustaining the current portfolio. The candidate will be expected to leverage on previous firsthand experience in order to exhibit domain expertise in the development of regulated clinical diagnostic tests (CE-IVD or FDA) with a focus on infectious diseases.

  • Subject matter expert for the development of regulated clinical tests for the diagnosis of infectious diseases
  • Devise effective and concise strategies for the verification and validation of regulated clinical tests that align with the shifting regulatory landscape in EMEA and the US
  • Authorship and execution of robust development, pre-verification, analytical verification and clinical validation plans in concordance with customer and product requirements
  • Work closely with QA/RA to provide guidance on pre-clinical and clinical routes for CE-IVD development
  • Direct line management of 4 direct reports at junior to staff scientist level
  • Effectively lead the verification and validation group with focus on scientific excellence from a customer centric stand-point
  • Provide technical leadership to scientists in all verification and validation related activities
  • Work closely with R&D leadership to manage staff development and increase employee involvement
  • Drive continuous improvement to decrease development time and cost
  • Represent the R&D department for cross-site collaborations and act as principal investigator for company sponsored grants
  • Deliver department level goals and instill the direction towards a 4i mentality

 

Qualifications

  • Essential – Bachelors in Biochemistry, Molecular Biology or similar
  • Preferred – PhD in Biochemistry, Molecular Biology or similar

 

Experiences

  • Bachelors plus 7 years industrial experience
  • PhD plus 4 years industrial experience
  • Experience in direct line management of a multidisciplinary team (>3 direct reports)
  • Experience and demonstrated success in project leadership roles relating to genetic analysis
  • Experience in strategizing, planning and executing complex verification and validation studies in diverse product areas (e.g. regulated medical devices to research use only instrumentation)
  • Demonstrated experience in the successful development and commercialization of regulated clinical tests in the infectious diseases arena (CE-IVD or FDA)
  • Previous authorship of analytical verification and clinical validation plans for the interrogation of product and customer requirements in a regulated space (CE-IVD or FDA)

 

Preferred competencies

The Senior Manager, Molecular Biology should possess a strong track record in the development of genetic analysis based products. This should come in the form of instrumentations and assays in both the research use and regulated space. Ideally, the candidate will be able to demonstrate previous cross-functional experience in the development of regulated clinical tests with particular emphasis on assay design and development, sample preparation, assay integration and pre-verification, analytical verification and clinical validation, lyophilization and manufacturing, project management and post market surveillance. Furthermore, this should be complemented with strong fundamental understanding of current technologies in the life sciences.

  • Significant and demonstrated success in leading and implementing PPI and 5S
  • Keen interest in financials and project budgeting
  • Demonstrates strong communication skills through formal and informal discussion with peers, supervisor and upper management
  • Mentors and manages groups effectively by creating compelling staff development plans and actionable SMART goals
  • Plays a major role in shaping the technical vision/mission of the department
  • Reinforces strong relationships within R&D and other departments as well as outside collaborators and customers

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