Specialist, Quality Control, Bioassay

The Role:

Reporting to the Supervisor of Clinical QC- Bioassay, the Quality Control Specialist will be responsible for GMP release and stability testing at Moderna’s GMP manufacturing facility based at their Norwood, MA site. The individual will troubleshoot assay methods and support investigations for OOS and other non-conforming results. The role will contribute to the implementation of Bioassay testing capabilities, related method transfers and qualification activities, investigations, and assay/instrument troubleshooting. The individual will teach and train analysts on the Bioassay team. You will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance and Development.

Here’s What You’ll Do:

• Support bioassay testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies.

• Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities, including Sequencing and qPCR assays as required.

• LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS

• Lead special projects as Bioassay SME in support of clinical operations.

• Conduct technical assessments of deviations and investigations.

• Train junior laboratory staff on Molecular Biology methods.

• Review SOPs, protocols, and reports.

• Troubleshoot issues related to equipment, laboratory procedures and assay performance

• Perform general laboratory support activities including reagent preparation, equipment maintenance, etc.

• Establish and maintain a safe laboratory working environment.

• Accept, complete, and report on assignments within the agreed upon timeframe.

• Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations.

• Provide support to audit teams for internal and vendor audits.

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 Molecular Biology and DNA Sequencing.

• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations

• Knowledge and hands-on experience performing and troubleshooting Sanger Sequencing and qPCR.

• Demonstrated knowledge of method qualifications.

• Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way.

• Proven ability to conduct investigations.

• 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)

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with 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. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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.