Manager, External Quality Control

Employer
Moderna
Location
Massachusetts
Salary
Competitive
Posted
March 20 2017
Organization Type
Biotech
Job Type
Manager
Manager, External Quality Control

Position Summary

Moderna is seeking a Quality Control Manager for a position based at their Cambridge, MA site that will transition to our Norwood, MA manufacturing site next year. The individual in this role will support external testing and program activities for outsourced late phase clinical manufacturing.  He/she will assist in establishing testing program requirements and will support investigations for out-of-specification and other non-conforming results as well as troubleshooting of assays. The individual will act as interdepartmental liaison to various groups as well as Quality Control contact to the contract manufacturing organizations and testing labs. The successful candidate must have a minimum of 8-10 years of industry experience with focus in chemistry.

Responsibilities

  • Assist in establishing testing program requirements at contract manufacturing organizations and contract laboratories for raw materials, drug substance and drug product
  • Participate in cross-functional project team to lead Quality Control related activities
  • Oversee method transfers and validations projects as required
  • Troubleshoot and provide further technical support for method, material, and instrument-related issues
  • Review/approve procedures, protocols and reports
  • Support technical assessments of deviations and investigations
  • Manage release and stability testing, data trending, analysis and reporting
  • Author CMC sections for regulatory filings

Qualifications

  • Minimum education required: Bachelor's degree in a relevant scientific discipline
  • Minimum experience required: minimum 8-10  years in a cGMP laboratory with focus in analytical chemistry
  • Minimum knowledge required:  cGMP, USP/EP compendia testing requirements
  • Minimum skills required: compendia raw material and analytical chemistry test methods, technical writing
  • Demonstrated knowledge of method transfers and qualifications
  • Proven ability to conduct investigations
  • Strong written and oral communication skills as well as organizational skills
  • Ability to travel occasionally to support project activities
  • Preferred Education: Bachelor's degree in a relevant scientific discipline
  • Preferred Experience: minimum 8-10 years in a cGMP laboratory with focus in analytical chemistry
  • Preferred Knowledge:  LIMS

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Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.