Supervisor, Quality Control
Reporting to the Director of Quality Control Chemistry, this individual will be responsible for leading Moderna's expanding Quality Control Sample Management department. This role will be crucial in the establishment of QC operations at new Moderna Norwood, MA site. This role will also play a critical part in stability operations as well as digital data management and the expansion of electronic systems capabilities in Quality Control. This position will initially be based in the Moderna Cambridge, MA location and will transition to our new cGMP Clinical facility in Norwood, MA facility by the end of June 2018.
Here's What You'll Do:
- Build and lead the Quality Control Sample Management team
- Provide support to the Quality Control Stability team (stability sample and data management)
- Play a key role in the expansion of quality control digital systems
- Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations
- Actively develop direct reports by seeking opportunities for cross training within and outside quality control
- Establish and maintain a safe laboratory working environment
Here's What You'll Bring to the Table:
- BS/BA and minimum 5-8 years in cGMP environment. 2+ years in a leadership role.
- In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Experience working with contract test labs, vendors, and relationship management preferred.
- Working knowledge of ICH stability program management.
- Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.
- Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively.
- 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.
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.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.