We are looking for a high energy, hands-on, and detail-oriented operations leader (reporting to the CEO) to set up a world-class production organization and processes for both internal and external production.  This role will include the development and management of the internal production organization for a mostly reagents-based product and is anticipated to evolve over time from a small narrowly focused team to one supporting a variety of product lines and regions. The candidate is expected to work collaboratively with the Product Development, Sales, Accounting, and supplier teams to drive the rapid deployment of new products, and meet both order and quality demands.

Requirements and desired experience:

  • Bachelor’s degree or higher in Biomedical Science, Biochemistry, Molecular Biology, Bioengineering, Chemical engineering or related fields preferred
  • 6+ years in the biotech industry, working in operations organizations
  • Strong background in the NPI process, particularly in setting up new teams
  • Technical knowledge of automation hardware and software related to biomolecular techniques preferred
  • Knowledge and understanding of production process, work instructions, documentation configuration control, non-conforming & rework documentation requirements 
  • Expertise in process failure mode and effects analysis (pFMEA) and corrective and preventive action (CAPA)
  • Experience with Good Manufacturing Practice (GMP) is a plus
  • Experience with international shipping guidelines
  • Experience with Enterprise Resource Planning (ERP) tools
  • Applicants with experience in a fast-paced startup culture highly desirable