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Job ID :
61827BR
Location :
US - California - Fremont
:
Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.


How will you make an impact?

The Senior Manager of Product Development will coordinate and manage all Product Development activities for new product development. Areas of responsibility include: concept feasibility review, protocol writing, execution of verification studies, validation plan, raw material specification, analytical methods development, QC methods for testing, abd product transfer to Manufacturing Engineering group while driving projects through Design Control to successful launch.


What will you do?

  • Manage the activities and resources associated with product development process, application development and design control. Ensure that Regulatory Affairs (RA) and Quality Assurance (QA) requirements are met in accordance to FDA and ISO guidelines for design control.
  • Manage the creation of draft documentation controlling production and testing procedures, that meet product performance requirements and are reproducible and QSR/ISO compliant.
  • Contribute to product performance risk assessments.
  • Manage business process for new application development.
  • Responsible for Toxicology, TDM, Companion Diagnostics, Quality Controls and Mass Spectroscopy assay development.
  • Interface with multiple groups including Technical Operations, Research, Project Management group, System Integration and Product Support.
  • Develop technical expertise of subordinates required to perform functions in a dynamic technical field.
  • Assure all teams are in the adherence to Good Manufacturing Practices (GMP).
  • Assure compliance with corporate site and regulatory policies, practices and guidelines.
  • Lead and direct continuous process improvement projects that lead to best practices and consistency of the product development process.
  • Support establishing team goals and career development; conducts performance reviews for employees and creates an environment of career growth and continuous improvement.
  • Develop and maintain a flexible organization such that fast changing priorities can be accommodated with minimal disruption.


How will you get here?

  • PhD in Chemistry or related field with 5-10 years of industrial/professional experience; M.S in Chemistry or related field with 10-15 years of relevant industrial experience; a Bachelor degree may be accepted with the relevant amount of experience.
  • A minimum of 5 years proven experience managerial experience with proven ability to lead, coach/mentor, and develop a high performing R&D team.
  • Experience in In Vitro Diagnostics with in-depth knowledge of Design Control in the IVD environment.
  • Demonstrated good understanding of ISO and cGMP.
  • Must be able to work in a demanding fast paced environment and coordinate numerous activities with a multi-disciplinary team of scientists who need to communicate and cooperate to achieve maximum efficiency.
  • Self-motivated, independent and a proactive driving force of efficient execution.
  • Demonstrated strong organizational and project management skills.
  • Excellent written and oral communication skills; strong interpersonal skills, highly collaborative within a multi-discipline team and contribute to a supportive and positive work environment.
  • Ability to identify technical risks and mitigation strategies to keep the product launches on schedule.
  • This position may require up to 10% travel, some of which will take place outside of the typical office hours.


At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.


Apply today! http://jobs.thermofisher.com


Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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