Associate II, Quality Assurance

Employer
Moderna
Location
Massachusetts
Salary
Competitive
Posted
March 21 2018
Organization Type
Biotech
Associate II, Quality Assurance

The Role:
Moderna is seeking a Quality Assurance Associate II for a position based in Cambridge, MA. This position will transition to the Norwood, MA manufacturing site to support a Sunday-Wednesday or a Tuesday-Saturday shift. This position will be a part of Moderna's Personal Vaccine Unit (PVU) Quality Assurance team responsible for ensuring quality oversight of the PVU platform in cGMP Manufacturing.  This position will support the successful release of PVU products to the clinic in a timely manner. The main responsibility for this position will be performing reviews of batch documentation and QC testing data of the manufacturing processes for PVU plasmid DNA, drug substance, and drug product both manufactured internally an and at the CMO. This position will also assist in the startup activities required to initiate drug product cGMP manufacturing operations at the Norwood facility. Success in this position requires batch release experience 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.  Regular (up to 25%) travel will be a requirement for this position. 

Here's What You'll Do:

  • Support disposition of drug substance and drug product manufactured by the CMO. Review pre-executed batch records and perform an independent technical review of post-execution documentation of cGMP activities for PVU drug product manufacturing.  Ensure all specifications are met and that applicable requirements are completed and acceptable. 
  • Participate in providing quality oversight to CMO of manufacturing, testing, and real-time observations of activities.
  • Identify, classify and report deviations as appropriate and typically work on more complex minor and/or major deviations.  Oversee execution of remediation/CAPA activities required to continue production or move a process to the next mile stone.  Work closely with others to determine root cause and potential preventative/corrective actions.  Ensure timely closure of investigation.
  • Assist in the creation and review of procedures to ensure compliance and adherence to regulations and cGMP operations.
  • Provide support to the startup activities required to set up cGMP manufacturing operations at the Norwood, MA facility.
  • Work closely with team members to recognize opportunities for improvement and help drive change through the use of Quality Systems.

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

  • Requires a Bachelor's degree in Microbiology, Biology, or Chemistry
  • Minimum 2 years of Quality Assurance experience in pharmaceutical industry providing oversight to manufacturing operations
  • Demonstrated knowledge of cGMPs in a manufacturing environment
  • Strong independent judgement and decision-making abilities
  • Demonstrated problem detection and problem resolution skills
  • Must possess demonstrated organizational skills
  • Must possess excellent verbal and written

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.
  • 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.
  • Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com

Why join Moderna Therapeutics

We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry. 

Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage. 

We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world. 

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 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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