Sr. Manager, Manufacturing Science and Technology
This position is a new role established to support increased cGMP Manufacturing activities at Moderna's Norwood site. Reporting to the Head, MST, the Sr. Manager will be responsible for managing technology transfer, and be the MST lead for sustaining cGMP manufacturing operations, for plasmid production at Norwood. This includes both small scale plasmid production for the Personalized Cancer Vaccine as well as large scale plasmid production for use in Clinical Production.
Here's What You'll Do:
- Lead cross functional Technology Transfer teams for plasmid projects. Track and coordinate project milestones to enable cGMP compliant implementation.
- Work with Manufacturing, Facilities, Digital, and Quality to implement additional production trains in both small scale and large-scale plasmid production.
- Partner with Technical Development, Manufacturing, and Quality to enable and sustain cGMP processes. Be the technical lead supporting cGMP manufacturing activities.
- Be the subject matter expert for plasmid processes at both small and large scale. This includes supporting equipment commissioning/validation, process transfer, MES implementation, troubleshooting, and leading technical investigations.
- Author process descriptions, technology transfer documents, deviation/investigation reports, technical reports, and manage technical CAPA/change controls.
- Establish and maintain process performance trending / metrics using digital information and statistical analysis tools.
- Establish and manage a MST team of Engineers and Associates to support these activities.
Here's What You'll Bring to the Table:
- Biochemical engineer, Chemical engineer, or Biochemistry background. Ph.D. with 2-5+ years experience or MS with 8+ years experience or BS with 10+ years of experience in a pharmaceutical or biotechnology company.
- Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.
- Demonstrated expertise bioprocessing of protein and/or nucleic acids. Expertise in at least one of the following areas: chromatography, membrane separations, fermentation, enzymatic reactions, and formulation.
- Technical agility. The capability to manage diverse technical areas.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Experience in biologics process development and scale up / scale down.
- Experience with single use bioprocessing technologies.
- Proven track record leading and managing cross functional teams.
- Knowledge of digital cGMP tools. For example: SAP, OSI PI(), MES (eBR), Unicorn, eQMS
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
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.