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Manager – Product Transfer
Molecular Assays
Confirmed live in the last 24 hours
Locations
San Diego, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Research
Requirements
  • Ph.D., Master or Bachelor's degree in a biology, chemistry or scientific discipline, with at least 5-10 years of experience in the healthcare/biotech/pharmaceutical industry
  • The candidate must have experience in design transfer from product development to commercial manufacturing processes in the biotechnology arena, preferably in an FDA regulated environment
  • Biochemical - knowledge and extensive hands-on experience with mathematical calculations pertaining to chemical formulations, enzyme activity assays, and a thorough understanding of current molecular biology techniques, especially qPCR
  • Experience with evaluating and transferring injection molded components and other plastics/consumables into a manufacturing environment desirable
  • Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions
  • In-depth experience with process and product validations, specification setting and test method validations, and FDA design control documentation is required
  • Excellent Project Management successes with expertise influencing key decision makers within a matrix environment
  • Working knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferred
  • Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential
  • Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner
  • Manage, develop, retain employees
Responsibilities
  • Responsible for transferring and validating assay formulations, QC methods and testing processes into manufacturing
  • Development of QC Gold Standards and Stocks
  • Overall responsibility for creating and approving Product BOMs, Specs, Work Instructions and other documentation as the Design Transfer head for new assay introductions
  • Collaborates with supply chain to procure new raw materials as needed
  • Designs and oversees appropriate stability studies and quality testing plan for any new raw materials and/or formulations required for newly developed products, ensuring robust performance
  • Drafts finalized design tree containing all QC production steps from raw material to final bead formulation
  • Initiates order of pilot materials for R&D Phase 2 studies
  • Responsible for overall project management of the Product Transfer Teams and major cross-functional projects, including planning, tracking, and facilitating functions
  • Acts as a catalyst and primary contact for multiple functional areas across project teams, present to senior management project status, plans, issues and recommendations as well as negotiate key stakeholders including Quality, Regulatory, Assay Development, and Operations
Desired Qualifications
  • Experience leading design transfer activities for medical devices in international markets is a plus
Quidel

501-1,000 employees

Diagnostic healthcare manufacturer
Company Overview
Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of families, communities, and the world. The company is delivering a continuum of diagnostic solutions from advanced lateral-flow, direct fluorescent antibodies, and molecular diagnostic tests that improve the quality of healthcare.
Benefits
  • Medical, dental, & vision
  • 401k
  • Income replacement
  • Employee stock purchase plan
  • Vacation & Holidays
  • Great work environment
Company Values
  • Customer Driven
  • Focused on Execution
  • New Product Oriented
  • Determined
  • Optimistic
  • Team Players