Supervisor, Quality Control (Microbiology)

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
April 20 2019
Ref
R1592
Organization Type
Biotech
Supervisor, Quality Control (Microbiology)

The Role:

Reporting to the Senior Manager of Quality Control (Microbiology), the Quality Control Microbiology Supervisor will be responsible for leading QC Microbiology's product testing group. The QC Microbiology Supervisor will play a critical role in development of analyst in support of microbiological method transfer, qualification and release testing for GMP QC raw material, drug substance and finished product testing for mRNA products produced at Moderna's manufacturing facility and affiliated contract organizations. He/she will contribute to the implementation of QC Microbiology testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting.

Here's What You'll Do:
  • Effectively coordinate the execution of product testing to ensure on time delivery of test results.
  • Actively develop direct reports by seeking opportunities for cross training within and outside quality control.
  • Oversee day to day laboratory operations to ensure compliance with quality systems.
  • Collaborate with development groups for method transfers and qualifications in support of expanding the GMP QC Microbiology laboratory capabilities, including Sterility testing, Bioburden Analysis, Endotoxin, TOC and Conductivity Testing utilizing both standard and rapid methods.
  • Support testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies
  • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Assist with equipment qualification / validation activities, including maintenance
  • Troubleshoot issues related to equipment, laboratory procedures and assay performance
  • Conduct technical assessments of deviations and investigations
  • Oversee general laboratory support activities including reagent preparation, equipment maintenance, etc.
  • Write/revise SOPs, technical protocols and reports
  • Offer input and suggestions for improvement in laboratory operations and procedures
  • Train and provide technical guidance to other microbiologists


Here's What You'll Bring to the Table:
  • BS/BA in a relevant scientific discipline with a minimum of 5-8 years (or MS in a relevant scientific discipline with 2-5 years) Quality Control experience in a cGMP organization with a focus in Microbiology
  • Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
  • Expertise in Vitek, BET, MODA, Isolator Technology
  • Demonstrated knowledge of method development and qualifications
  • 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)


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays with 2 personal days.


Why join Moderna Therapeutics

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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Moderna is a smoke-free, alcohol-free and drug-free work environment.

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.

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