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Job ID :
44350BR
Location :
US - California - Fremont
:
Job Description

Position Summary:

Responsible for supervising all activities in the LC-MS Reference laboratory and hapten synthesis group. Group is responsible for developing and validating LC-MS methods used to support manufacturing and R&D. The group is also responsible for hapten synthesis and purification. The Senior R&D Manager works closely with R&D and manufacturing. Develops targets for Antibody development in support of assay development. Works with the Director of R&D to define and implement new product opportunities, prioritize projects, manage budget and costs estimates of products manufactured in the group. Manage and prioritize projects based on inventory and direct staff in preparing rare reagents to support manufacturing activities.


Key Responsibilities:

  • Responsible for hiring, supervising and training scientists.
  • Ensure all processes are document according to GMP and methods are validated. Transfer to manufacturing or develop documented processes to support the synthesis and purification of compounds involving multistep synthesis from milligram to multi gram scale.
  • Oversee LC-MS method development and validation. Establish process for value assignment of calibrators and traceability to known standards.
  • Complete Performance Reviews for direct reports using the performance management process as a valuable tool for supporting employee development and improvement.
  • Lead, mentor and develop employee’s including fostering a culture of collaboration.
  • Oversee the preparation of manufacturing documents including SOPs and specification sheets. Work with the team for the successful transfer of conjugates, SOPs, and other needed documents to Operations.
  • Strong communication skills and ability to coordinate with multiple functional teams is a must.
  • Perform all activities in compliance with GMP, regulatory and safety policies.
  • Drive continuous improvement and incorporate Good Document Practices for configuration management, batch records and traceability for materials or methods developed within the group.
  • Collaborate with other departments in the organization to resolve technical issues related to the product manufacturing, testing and performance. Participate in efforts to exhibit a positive impact on product quality and perception of the company in the marketplace.


Minimum Requirements/Qualifications:

  • Ph. D in Chemistry (or related major) and 5-10 years of industrial experience or M.S in Chemistry (or related major) and 10-15 years of industrial experience.
  • Experience in LC-MS assay development is a must.
  • Experience in In Vitro Diagnostic (IVD) is a plus.
  • Must be able to work under pressure and coordinate numerous activities with a multi-disciplinary team of scientists who need to communicate and cooperate to achieve maximum efficiency.
  • Excellent written and oral communication skills.
  • Excellent organization and strong project management skills.
  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contribute to a supportive and positive work environment.
  • Self-motivated, independent and a proactive driving force of efficient execution.
  • Capable of multi-tasking and changing priorities caused by time, markets, customers, budget or other constraints.
  • Good understanding of ISO and cGMP. Familiar with design control and all regulatory requirements related to IVD products.
  • Ability to identify technical risks and mitigation strategies to keep the product launches on schedule.


Non-Negotiable Hiring Criteria:

  • This position does not offer Relocation Assistance.
  • Ph. D in Chemistry (or related major) and 5-10 years of industrial experience or M.S in Chemistry (or related major) and 10-15 years of industrial experience.

*IND-SDG


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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