Director

We are seeking an expert with Molecular Assay Development & Commercialization experience

  • San Carlos, CA
  • $130,000 - $190,000
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A bit about us:

We are a Series C startup with new assay development on the horizon and we are utilizing cutting-edge molecular and automation technology to make global impact to help combat diseases & pathogens through the power of genomics. We are a seeking humble and ambitious individuals to help us achieve our goals and make great impact at scale with our work

Why join us?

We offer competitive pay, excellent benefits, flexibility, great office/lab amenities including catered food each week, and equity so you'll have a piece of the pie! We are a cohesive collaboration and as a team, achieve aggressive milestones & work together to reach the goals

Job Details

Lead a cross-functional team in the transfer of RUO and IVD products to manufacturing/operations
Participate in the creation of project plans with Project Management and oversee there execution by the cross-functional team according to RUO and IVD Design Control processes
Write, review, and approve all levels of technical documentation – protocols, reports, MPRs, SOPs, QC Specifications, DMRs, etc - during design transfer to Manufacturing/Operations and QA.
Transfer and qualify/validate (as required) test methods to QC to assess raw materials, bulks, and Finish Good (FG) product specifications
Participate in IVD product design validation studies and the generation of data for regulatory FDA submission and IVDD/CE Mark.
Provide IVD product information, data summaries and other required documentation to support FDA regulatory submissions/CE Mark IVDD Technical Files
Provide manufacturing technical support for products undergoing Change Control, CAPAs (Root Cause Analysis), Risk Analysis (FMEAs), and NCPs within the Company’s Quality System
Manage and mentor product transfer scientist, research/development scientists, and manufacturing/QC personnel
Provide technical support to manufacturing, QA, QC, RA and marketing/sales
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Job Details
Managed by Jobot Pro
Location
San Carlos, CA
Job Type
Permanent
Compensation
$130,000 - $190,000