Engineer, Quality Assurance

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
March 07 2019
Ref
R1410
Discipline
Life Sciences, Biology
Organization Type
Biotech
Engineer, Quality Assurance

The Role:
Moderna is seeking a Sr. Engineer, Quality Assurance for a position based at their 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 clinical processing at the Norwood Site. 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 manufacturing operations at Moderna's new facility in Norwood, MA.

Success in this position requires expertise in all aspects of GMP 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:
  • Write, review and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
  • 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 and approve validation protocols and reports to ensure compliance
  • Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
  • Support disposition of raw materials, drug substance, and drug product
  • Review stability protocols and reports
  • Collaborate with Manufacturing to resolve equipment and process issues
  • Conduct internal audits, track progress, and trend results
  • Lead/participate in supplier audits
  • Review relevant sections of regulatory filings


Here's What You'll Bring to the Table:
  • BS/MS in a scientific or engineering discipline
  • Five to eight years experience in the pharmaceutical/biotech industry with a BS/BA degree, with a minimum of
  • four years experience in Quality Assurance or two to five years experience in the pharmaceutical/biotech industry with an MS degree, with a minimum of two years experience in Quality Assurance
  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
  • 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.
  • Ability to adjust to changing timelines and priorities
  • Work effectively with cross-functional teams
  • Ability to take a hands on approach when needed and balance with ability to take high-level approach to resolve challenges


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • 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


Why join Moderna Therapeutics

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.

#LI-PL1

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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