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 4 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, Rapid Microbiological Methods, and/or Isolator Sterility Testing and 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 or catered lunches
• 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
• Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• 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)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .

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.