Supervisor Clinical Quality Control

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The Role:
Reporting to the Manager/Director of Quality Control, this individual will be responsible for leading the part of Clinical QC Chemistry Operations team. The individual will directly oversee the Chemistry function in support of QC raw material, drug substance and finished product testing for mRNA products produced at Moderna’s manufacturing facility. He/she will oversee the implementation of chemistry testing capabilities, related method transfers, investigations, and assay/instrument troubleshooting. The individual will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance, Regulatory and Development. 

Here’s What You’ll Do:

• Manage a team of specialists/associates in support of Clinical QC Testing for Stability, Release and In process samples.  

• Coordinate training, professional development and growth of the QC Associate and Specialist teams.

• Manage authoring of quality systems records such as deviations, change controls, CAPAs

• Leads Troubleshooting of methods and equipment.  

• Execute test methods & assays as needed to support team throughput.

• Review of Executed assay packages, in both paper and electronic formats.  Includes review of chromatography data and other analytical outputs.

• Participate in cross functional planning to align QC resources and constraints with business objectives.  Prepare, provide and manage schedules for testing.

• Coordinate and Manage Stability testing in partnership with QC Stability Team. 

• Develop and manage scheduling and status monitoring tools to measure testing capacity, turnaround time and to communicate progress to the larger organization.

• Participate in and partner with the Digital team to expand and optimize the use of the LIMS (LabVantage) system.   

• Provide guidance and support to the QC-Chemistry team for compliance issues.  Support preparation, management and response to compliance audits. 

• Establish and maintain a safe laboratory working environment

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

• BS/BA and minimum 5-8 years in cGMP Quality Control environment. 1-3 years in a leadership role.

• In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.

• Experience and technical knowledge of analytical methodology.  HPLC experience is a must have, additional experience with particle analysis and plate based assays is preferred.

• Proficiency and experience with scheduling, planning or project management skills, including detailed instrument and analyst scheduling.

• Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.

• Experience with statistical data analysis

• Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs

• Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively. 

• Outstanding communication skills (verbal and written). 

• Ability to manage multiple projects in a fast-paced environment. 

• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

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 ****target=_blank rel=no-follow>****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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