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 Clinical Diagnostics Division of Thermo Fisher Scientific is looking for an experienced Senior Manager - R&D Assay Research to lead the R&D Research group at their Fremont, CA facility. The Senior Manager is an experienced people manager with the ability to lead and develop junior and senior technical staff and manage the R&D laboratory. Additionally, this person will contribute to analytical methods development, be the subject matter expert on a global cross-functional team working on developing in-vitro diagnostics (IVD) systems and assays for clinical use. Clinical reagents and reference methods will be designed to support testing in Toxicology, Therapeutic Drug Monitoring, Immunosuppressive Drug Monitoring and Companion Diagnostics.
What will you do?
People and Laboratory Management:
- Lead, manage and supervise a group of individual contributors as well as other managers.
- Manage day-to-day analytical lab operations and provide guidance to technical staff on work priorities, resolving issues and ensuring project work is completed with high quality in a timely manner.
- Participate in the biannual performance assessment process and execute the Performance Management & Development (PMD) Process to set robust performance goals, differentiate performance, reward high performers and hold people accountable by addressing performance issues.
- Recruit and onboard new talent. Develop a robust succession plan and career development plan that meets the needs of both the business and the individual.
- Manage local R&D budget. Approve material purchase requests, reconcile monthly expenses, approve equipment repair and maintenance requests and help plan and execute capital investments.
- Learn and ensure self and team are in full compliance with various quality systems requirements (QSR) and procedures established by the company to maintain certification and good standing with various regulating agencies such as the US FDA and CE IVD.
- Help improve processes using practical process improvement (PPI) tools to reduce waste and improve quality. Ensure seamless exchange of information and work across functions in a global organization.
- Drive continuous improvement and incorporate Good Document Practices for configuration management, batch records and traceability for materials or methods developed within the group.
- Lead the design, proof-of-concept and evaluation of test methods through the Feasibility of clinical assays including analytical methods and assay reagents such as calibrators and controls, under design control. Take ownership for successful execution of project plan and outcomes that meet or exceed product design requirements and customer needs.
- Maintain a GMP level laboratory to conduct test method development and validation. Build and manage capability to be a reference laboratory for LCMS analysis. Provide support to manufacturing group for assay reagent value assignment, calibrator traceability and raw material characterization, as needed.
- Manage exploratory and early-stage research activities dedicated to new clinical LCMS methods and feasibility studies.
- Develop specifications for assay reagents and consumables. Work with internal and external development teams to successfully transfer methods and reagents to the development group.
- Collaborate globally across functions and businesses to execute, document and troubleshoot analytical methods with full transparency and urgency. Identify and manage project risks related to project schedule and budget including those related to systems integration. Efficiently track and communicate progress on individual tasks and milestones using variety of tools.
How will you get here?
- Ph. D in Chemistry or related filed with 5-10 years of industrial experience or M.S. in Chemistry or related field with 10-15 years of industrial experience.
- A minimum of 5 years proven managerial skills - managing, developing and leading people with various levels of seniority. Ability to deal with conflicts and hold people accountable. Experience in analytical method development in an IVD environment is a must.
- In depth knowledge of Design Control in the IVD environment. Demonstrated good understanding of ISO and cGMP as applied to medical devices industry.
- Prior experience executing complex projects in a global environment. Demonstrates 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.
- High degree of integrity, intensity and independence. 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.
- Ability to travel up to 10% including internationally, some of which will take place outside of the normal business hours. Flexible schedule in order to take early-morning conference calls with colleagues and collaborators across continents and time-zones.
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.