Sr. Manager Quality Assurance
Moderna is seeking a Senior Engineer reporting to the Senior Director Quality Assurance. The individual in this role will be responsible for collaborating with the technical and analytical development organizations to provide Quality support and lead Quality improvement initiatives. The individual will work with technical and analytical development to ensure robust processes and systems are implemented in support of Moderna's CMC development programs. This individual will develop and implement quality systems / standards driving best practices ensuring data integrity in laboratory notebooks, development history reports and IND filings. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.
Here's What You'll Do:
- Provide guidance on best practices for sample management, data integrity and investigation
- Develop and implement research appropriate quality systems
- Collaborate with the technical development organization to establish efficient quality focused processes in technical development
- Write, review and approve research documentation (SOPs, protocols, technical reports, specifications, etc.)
- Lead investigation, change management and risk assessments for CMC development.
- Review regulatory submissions for data accuracy and traceability
- Develop training materials and train the technical development organization on key quality systems
- Performs compliance monitoring of technical development to ensure adherence to established practices for consistent and accurate data reporting.
- Attends Research and CMC meetings as needed.
Here's What You'll Bring to the Table:
- BS in a scientific or engineering discipline with 10+ years of experience or MS with 8+ years of experience in the pharmaceutical/biotech industry, with a minimum of 2 years of technical experience
- Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical/biotech products
- Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance
- Experience in reviewing and approving research related documents (SOPs, protocols, reports, batch records, etc.)
- Solid understanding of CMC requirements for INDs, BLAs, and other regulatory filings
- Experience in participating in deviation investigations, determining root cause, and developing corrective action plans
- Ability to identify technical problems and suggest resolution of the issues
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
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.