Manager, IVD Scientist

Location
Fremont, CA
Salary
Competitive
Posted
April 28 2017
Ref
48294BR
Position Type
Full Time
Job Description

Position Summary:

The Thermo Scientific Controls business is a group of passionate individuals committed to changing the way medicine is practiced. This role will be dedicated to leading a talented team of scientists (PhD and below), developing IVD products for the Thermo Scientific Controls business, including MAS and AcroMetrix brands. This is an opportunity for a highly motivated IVD scientist to work in a fast-paced environment and develop diagnostics at the cutting edge of technology and medicine.

The ideal candidate will be a team player who is passionate about delivering simple, effective, customer-focused products. The successful candidate will incorporate IVD and molecular biology experience to develop robust, innovative control materials for diagnostics. This position will also function in leading partnerships and collaborations with renowned investigators at research institutions, standards organizations, industry, and clinical laboratories worldwide.

Key Responsibilities:

  • Control product development
  • This is partially a hands on bench scientist position, including managerial responsibilities
  • Provides innovative ideas for new products, new customer-focussed technologies and intellectual property
  • Collaborates with molecular biologists, chemists, bioinformaticians, engineers, product managers, customer support, internal cross functional core teams and external scientists
  • Executes IVD development experiments, from proof of concept through to validation, regulatory submission and launch
  • Actively participates as a member of cross-functional product development teams
  • Performs statistical analysis and practices DOE methods
  • Represents the company at scientific meetings, gives talks and presents posters
  • Some travel may be required to visit customers, collaborators, and attend conferences
  • Documentation under design control to ensure quality product development

Minimum Requirements and Qualifications:

  • PhD in Molecular Biology / Genetics / Biochemistry / Organic Chemistry / Bioengineering with at least 5 years of experience
  • Strong experience in IVD product development, following ISO 13485, 21 CFR Part 820 Quality Systems Regulation, GLP/GMP, and Design Control
  • Will have launched at least one 510(k) product
  • Has experience managing a team with direct reports, including hiring
  • Multidisciplinary background
  • Demonstrates passion for problem solving and outside-the-box thinking
  • Demonstrates passion for mentoring and team development
  • Strong communication and presentation skills are essential
  • Must be highly collaborative; Have the ability to work within a diverse team and contribute to a supportive, positive work environment both within the team and in the greater community
  • Self-motivated, independent, and a proactive driving force of execution
  • Has statistical skills using current platforms eg. JMP
  • Willingness to take on new challenges
  • Can clearly document product development. Quality of documentation must support patent claims and IVD product development
  • Is extremely organized and driven to complete projects efficiently
  • Willingness to be flexible and adaptable in a complex, matrixed environment
  • Able to adapt to changing needs caused by time, budget, or other constraints



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.