Sr. Manager, QC Microbiology

Employer
Moderna
Location
Massachusetts
Salary
Competitive
Posted
August 25 2017
Organization Type
Biotech
Job Type
Manager
Sr. Manager, QC Microbiology

Position Summary

Reporting to the Director of Quality Control, the Quality Control Microbiology Senior Manager will directly oversee the Microbiology function in support of QC raw material, drug substance and finished product testing for mRNA products produced at Moderna's manufacturing facility and affiliated contract organizations. The Manager will oversee the environmental monitoring program, implementation of microbiological testing capabilities, related method transfer and qualification activities, investigations and assay/instrument troubleshooting. The individual will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance, Regulatory and Development.  This position will start in Cambridge, MA and transition to Norwood, MA.                                         

Responsibilities

  • Oversee implementation of in-house testing capabilities in the QC laboratory, including bioburden, endotoxin, and sterility assays as well as microbial identifications as required
  • Manages laboratory personnel and oversees their selection, performance management, mentoring, and career development
  • Assists in development of appropriate Standard Operating Procedures and training of personnel to ensure cGMP compliance
  • Manages laboratory investigations, change controls, and CAPAs for relevant QC operations
  • Contributes to budget and resource allocation
  • Interacts with Manufacturing, Quality Assurance, Regulatory Affairs and other Departments to:
    • Support testing for raw materials, drug substance and drug product internally and at CMOs and contract laboratories
    • Provide testing data and other required quality-related information needed to support clinical studies
  • Collaborates with development groups for method transfer and qualification activities as required
  • Assists in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Troubleshoots issues related to laboratory procedures and assay performance
  • Provides support to audit teams for internal and vendor audits

Qualifications

  • BS in a relevant scientific discipline with a minimum of 8 years Quality Control experience (minimum of 4 years management/supervisory experience) in a cGMP organization with a focus in Microbiology
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
  • Experience working with CROs, vendors, and relationship management preferred
  • Familiarity with electronic databases (e.g. MODA) preferred
  • Experience with rapid microbiology methods (preferred)
  • Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
  • Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment  
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Excellent communication skills (verbal and written)

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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.