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Manager, Quality Assurance (Drug Product)

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Closing date
Nov 8, 2019

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Discipline
Life Sciences, Biology
Job Type
Research Scientist
Organization Type
All Industry, Biotech

Job Details

The Role:

Moderna is seeking a Quality Assurance Manager for a position based at our Norwood, MA manufacturing site. This position is part of Moderna's Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide quality oversight of Drug Product filling. The individual will work closely with Analytical Development, Process Development, Manufacturing, Materials Management, Quality Control, Digital, and the Manufacturing Science and Technology teams.

This position will also support the successful launch of Phase I and II products to the clinic in a timely manner. Ensure quality oversight is phase appropriate and scale-able. Assist in the startup of clinical drug product cGMP manufacturing operations at Moderna's state of the art manufacturing facility.

Success in this position requires expertise in all aspects of aseptic drug product manufacturing, the ability to work hands on, and the ability to collaborate in a cross-functional, fast paced environment.

Here's What You'll Do:
  • Lead Quality Assurance Team ensuring regulatory compliance in the manufacture of drug product.
  • Provide support for successful launch of phase I and II products to the clinic in a timely manner.
  • Ensure quality oversight is phase appropriate and scalable and will assist in start-up of clinical drug product Good Manufacturing Practice (GMP) manufacturing operations.
  • Author and review SOPs and policies and create and establish processes and procedures to ensure compliance and adherence to regulations and GMP operations.
  • Oversee execution of remediation activities to continue production and move processes to the next milestone.
  • Identify, classify and report deviations as appropriate and address complex deviations.


Here's What You'll Bring to the Table:
  • Master's degree in Regulatory Affairs, Pharmaceutical Science or related field (required)
  • 2 years of experience in regulatory compliance in the quality manufacture of therapeutic drugs (required)


Here's What We'll Bring to the Table:
  • On-site subsidized cafeteria
  • 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
  • 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)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

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; and 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). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

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

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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.

Company

Moderna is a clinical stage pioneer of messenger RNA (mRNA) Therapeutics™, an entirely new in vivo drug technology that directs the body’s cells to produces human proteins, antibodies and novel protein constructs, which are in turn secreted or active intracellularly. Founded in 2011, we are headquartered in Cambridge, Mass. 

Our Team and Mission

We currently have over 500 team members, an exceptional group of scientists and industry professionals who are wholly committed to advancing Moderna’s mission:  deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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