Sr. Specialist, Quality Assurance at Moderna Therapeutics in Norwood, Massachusetts

Job Description:

The Role:
Moderna is seeking a Senior Quality Assurance Specialist for support and Quality oversight of Large Scale Manufacturing Operations and Disposition at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced internally at Moderna. He/she will provide quality oversight and expertise to enable success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience working in a GMP facility with a functional background in either quality assurance, quality control, and/or manufacturing. They will be able to interact fluidly with peers and supervisors in Quality Control and the Facility departments. Additionally, they will be able to work cross-functionally with Quality Control, Manufacturing, and Facility/Engineering counterparts.

Here s What You ll Do:
- Participate in quality focused teams across Moderna s broad ecosystem of functions.
- Review Standard operating procedures.
- Oversight of Drug Product and Intermediate disposition.
- On the floor support when required for Investigations or Operations support.
- Lead cross functional meetings.
- Review major quality deviations.
- Review cleanroom and temperature unit alarms.
- Provide guidance and support to Operations.
- Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
- Participate in Audit support.
- Practice safe work habits and adhere to Moderna s safety procedures and guidelines.

Here s What You ll Bring to the Table:
- At least 5 years experience in a GMP manufacturing environment with a Bachelor s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
- Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
- Exceptional written, oral communication, and organizational skills required
- Experience with tech transfer desired.

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:
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

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, 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) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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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