The Role:
Moderna is seeking a Specialist of Quality Assurance Batch Disposition reporting to the Manager of External Quality Assurance, Batch Disposition. The individual in this role will be responsible for providing Quality support in batch disposition related to external aseptic fill/finish activities. The individual will work with contract manufacturing and internal functions to ensure robust processes and systems are implemented in support of Moderna's CMC development programs in conjunction with commercial filling milestones. This individual will execute based upon implemented quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems. This position will be 1st shift from 7:00 am to 3:00 pm working Monday through Friday.

Here's What You'll Do:

• Perform all activities required for commercial and clinical batch disposition




• Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met




• Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met




• Support Manager to collect and report targeted metrics for Management Review




• Support Quality Agreement review with contract manufacturers




• Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans




• Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations




• Conduct internal audits, track progress, and trend results




• Provide guidance on GMP manufacturing from Phase I to Commercial




• Support Annual Product Review report generation and approval as needed




• Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.) as needed

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

• BS with at least 4 years of experience, or a Master's level degree and 2 years' experience in the pharmaceutical/biotech industry




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




• Experience working with CMOs, vendors, and relationship management preferred.




• Experience working with aseptic fill and finish of vials preferred.




• Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.




• Knowledge of late-stage pharmaceutical development and validation principles preferred




• Excellent judgment and ability to communicate complex issues in an understandable way.




• Outstanding communication skills (verbal and written).




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




• Travel up to 10%.

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.

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