Specialist, Quality Control (Microbiology)

Specialist, Quality Control (Microbiology)

The Role:

Reporting to the Senior Manager of Quality Control (Microbiology), the Quality Control Microbiology Specialist will support microbiological method transfers, 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. The QC Microbiology Specialist uses expert knowledge of cGMP regulations and QC Microbiology processes to manage investigations and improvement initiatives within QC Microbiology operations.

Here's What You'll Do:

• Collaborate with development groups for method transfers and qualifications in support of expanding the GMP QC Microbiology laboratory capabilities including both standard and rapid methods.
• Utilize QC Microbiology knowledge and investigational skills to identify and resolve testing issues and drive continuous improvement in laboratory operations.
• Lead special projects as Microbiology SME in support of clinical operations
• Conduct technical assessments of laboratory data, deviations and investigations
• Write/revise method SOPs, technical protocols and reports
• 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

Here's What You'll Bring to the Table:

• BS in a relevant scientific discipline with a minimum of 2-5 years (or MS in a relevant scientific discipline with 0-2 years) Quality Control experience in a cGMP organization with a focus in Microbiology
• Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
• Knowledge of Vitek, BET, MODA, and/or Isolator Technology
• Demonstrated knowledge of method development, method qualifications, and compendial method verifications
• 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:

• On-site subsidized cafeteria
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• 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 (includes 2 floating holidays)

Why join Moderna

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.