Product Transfer Scientist III

Location
San Jose, CA
Posted
Apr 21, 2021
Required Education
Bachelors Degree
Position Type
Full time

San Jose based Visby Medical is an ambitious, well-funded, and fast-paced early-stage biotech startup. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Visby is developing a novel diagnostic device platform that aims to redefine the way infectious disease is tested and treated.

We are developing a tenacious team with the deep industry expertise of researchers, biologists, designers, and engineers that is back-stopped by world-class operations and administrative resources. If you enjoy tackling challenging problems, are passionate about your work product, and want to join a collaborative ownership team that is aiming to leave a lasting positive legacy in the healthcare industry, please consider the following Product Transfer Scientist III opportunity.

Summary

This Product Transfer Scientist III role is a position that requires a fundamental understanding of scientific principles and ability to drive systematic investigations and continuous improvement projects to completion. 

Essential Duties

Primary QMS Responsibilities:

  • Read and understand all assigned QMS documents. 
  • Follow GLP guidelines in documenting all work.
  • Follow work instructions and test protocols and properly document work forms as per Good Laboratory Practices. May create new documents, including test protocols, or update existing ones and submit deviations and DCO's.  
  • Writes QMS test reports and failure investigation reports independently. Uses professional judgment to determine when new documents are needed. Understands the NPI process (Stage gates, etc).
  • Develops production documentation including procedures, worksheets, purchase specifications and bills of material 

Primary Non-QMS Responsibilities:

  • Possess a strong ability to properly interpret experimental results and can independently make adjustments to experiments and/or studies as needed.  
  • Prepare and deliver presentations.
  • Uses extensive technical know-how to design and execute studies that include multiple experiments. Coordinates these activities with the team and maps out sub-projects.
  • Leads projects to ensure the continued production of cost-effective quality products and streamline processes.
  • Strong ability to solve complex problems either through the use of external publications (resources) or through management of multi-faceted projects. Double-checks the work of less senior team members and helps them to identify, understand, and solve problems.
  • Drive systematic investigations and continuous improvement projects to completion.
  • Analyzes data and participates in root cause analysis and design of solutions.
  • Provides technical guidance and assists in the professional development of team members. Often leads teams for studies.
  • Provide data and/or present information to internal and/or external partners and contribute to publications and patents. 
  • Contribute to scientific literature and conferences.
  • Able to frame technical details and projects as a story 
  • Coordinates with external vendors on technical projects.
  • May provide expert opinion on new lab techniques and equipment.
  • Keep work areas clean and organized.  
  • Participate in laboratory decontamination efforts.
  • Other duties as assigned

Education and/or Experience

  • B.S., M.S. or Ph.D.
  • Minimum 8 years of experience with a Bachelor’s degree; minimum of 6 years with a Master’s degree or a Ph.D.
  • Experience with reagent development and engineering/manufacturing.

Other Qualifications

  • Proficient in basic laboratory skills and possesses a strong knowledge for working with complex laboratory equipment such as thermocyclers.
  • May provide expert opinion on new lab techniques and equipment.  

Physical Demands

  • Comfortable performing repetitive tasks and/or motions.
  • Must be able to lift a minimum of 10 lbs.