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 Senior Product Transfer Scientist opportunity.

Summary

This Senior Scientist Product Transfer role is a position that requires a deep understanding of scientific principles and management such that they can lead a team to achieve success on complex projects. 

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 as per Good Laboratory Practices. Use professional judgment to determine if new documents, including test protocols, are required or existing ones need to be updated and submit deviations and DCO's.  
  • Writes QMS test reports, SOPs (Process flow) and failure investigation reports independently. Develop product documentation including procedures, worksheets, purchase specifications and bills of materials. Checks the SOP's and reports of less senior members.
  • Understands the NPI process (Stage gates, etc.) and may support high level documents such as product requirements, etc.

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. Provides input to other experiments and/or studies.
  • Prepares and delivers presentations.
  • May provide expert opinion on new lab techniques and equipment.
  • Takes ownership of a project, study or series of studies that requires extensive knowledge and the participation of cross-functional groups.
  • Maps out projects, sub-projects, and resources.
  • Serves as a technical liaison for other departments with regards to production activities, including control material, reagent formulation, and product or consumables testing. Should have substantial knowledge of validation and process control requirements. 
  • Lead, collaborate and participate in operations-related activities required for the transfer of new products to routine production.
  • 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 complex investigations and continuous improvement projects to completion.
  • Analyzes data and participates in root cause analysis and design of solutions. 
  • Apply rigorous statistics methodology to guide investigations and corrective actions.
  • Use external resources, publications, and technical knowledge to anticipate or solve complex problems. Ensure that problems encountered by the team are identified, understood, and solved.
  • Provides technical guidance and assists in the professional development of team members. Often leads teams for studies or projects.
  • 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 
  • Coordinate with external vendors on technical projects.
  • 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 10 years of experience with a Bachelor's degree; minimum of 6 years with a Master's degree or a Ph.D.

Other Qualifications

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

Physical Demands

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

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