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Sr. Manager, R&D Development & Transfer

Company: Thermo Fisher Scientific
Location: Pleasanton
Posted on: July 14, 2021

Job Description:

Job Title: Senior Manager, R&D Development & Transfer

Location/Division Specific Information

Pleasanton, CA | Genetic Testing Solutions

How will you make an impact?

The Genetic Testing Solutions group is a team of passionate individuals who are deeply committed to making the world healthier through development of molecular assays. This role will be responsible for leading a team to develop and commercialize products for both research and clinical applications on Thermo Fisher Scientific sample-to-answer platforms.

This is an opportunity for a highly motivated IVD leader to work in a fast-paced environment and develop diagnostics at the cutting edge of technology and medicine. The ideal candidate will be a passionate leader with a focus on teamwork, quality, and meeting customer needs. The successful candidate will incorporate IVD and molecular biology experience to develop robust and innovative diagnostics that make an impact on world health.

This position is responsible for product development and design transfer activities for new products from R&D to Manufacturing. The position requires utilization of both technical knowledge and lean concepts to manage the overall new product introduction activities ensuring that the resulting finished products meet all required safety, quality, and manufacturability by a process of robust design control that includes both product/process development and process validation activities. Leads the activities and resources associated with product development/transfer process and design control. Ensures that RA and QA requirements are met in accordance with FDA and ISO guidelines for design control that meet product performance requirements and are reproducible and QSR/ISO compliant

Responsibilities include interfacing with a number of Thermo Fisher functions in multiple divisions to influence/affect change and drive results, fostering relationships, managing conflict with confidence and integrity, and removing roadblocks to enable win-win for the company

The ability to effectively shift priorities and work at a fast pace is required. Excellent communication skills, including writing, articulating, listening, and questioning are essential. The ability to understand technical strategies and then translate those into broad/more simplified communications for cross functional collaboration is critical for success

This is a working manager position that will balance leading people and managing Programs/portfolios. The successful Sr. Manager will draw on a diverse background of skills such as people management, project management, technical expertise, risk-based validation, business acumen, and interpersonal savviness.

What will you do?

  • Lead multiple teams of managers and development scientists responsible for development and transfer of molecular assays to manufacturing
  • Manages relationships and alignment with internal and external partners
  • Develop high performing team through harnessing team diversity and growing top talent
  • Strong technical background in molecular diagnostics with specific experience writing and executing validation plans and reports.
  • Experience in process validation, documentation and reporting
  • Ensures projects meet timelines; identifies and removes roadblocks to ensure team success
  • Ensures products are adequately developed to enable smooth Design Transfer
  • Actively participates as a member of cross-functional product development teams
  • Leads high quality science and data-driven decision making, with a foundation in statistical analysis, DOE, and six sigma methods
  • Drives continuous process improvement
  • Strong knowledge in Design Control elements and considerable experience with Product Development and Design Transfer activities with other departments, and ability to manage multiple projects or assignments. Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVD-D, IVD-R and ISO 13485.
  • Ensures DHFs and technical files meet applicable standards. Documentation under design control to ensure quality product development.
  • Perform statistical analysis to analyze trends, and work with team(s) to conduct root cause analysis and to recommend and implement corrective actions for processes.

How will you get here?

Education

  • Ph. D in Molecular Biology / Biochemistry / Chemistry or related field with >5 years of industrial experience or M.S or B.S. with >10 years of In-Vitro Diagnostics experience (preferably in R&D or manufacturing).

Experience

  • Team management and team leadership experience
  • Strong experience in IVD product development, following ISO 13485, 21 CFR Part 820, Risk Analysis ISO 14971
  • Have launched 510k/PMA and / or List A CE-IVDD (or List D IVDR)
  • Design Control & Change control, and experience writing design quality records
  • Expertise in Process Capability / Six Sigma
  • Experience participating in audits

Knowledge, Skills, Abilities

  • Demonstrates passion for problem solving and outside-the-box thinking
  • Strong communication and presentation skills are essential
  • Must be highly collaborative; enjoys working in a diverse team and contributes to a positive work environment
  • Self-motivated, independent, proactive, organized, diligent, and very nimble
  • Experience in use of statistical programs including DOE
  • Strong project management skills
  • A Lean Expert with significant, hands-on track record of implementing successful TPS-based business systems including elements such as:
    • Lean Leadership (Daily Management, Leader Standard Work, and Gemba Walks)
    • Value-stream mapping
    • Follow-up kaizen blitzes on cell design, material flow, visual factory, etc.
    • Experience with 3P (Production Preparation Process) to optimize layout and product design

*EVRD2020 *GTSDouble

Keywords: Thermo Fisher Scientific, Pleasanton , Sr. Manager, R&D Development & Transfer, Other , Pleasanton, California

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