Associate Director, External Manufacturing
Reporting to the Head of External Manufacturing, the Associate Director will be the project leader and single point of contact for Moderna's Contract Manufacturing Organizations (CMO) to ensure on-time and in-full deliveries. This includes overall accountability to ensure all operational related activities at the CMOs are conducted to meet all of Moderna's requirements.
Here's What You'll Do:
- Act as Project Leader for GMP production at Contract Manufacturing Organizations (CMO).
- Act as a single point-of-contact to the CMOs to ensure on-time and in-full deliveries. Partner with supply chain, quality and technical development on all aspects of the relationships with the CMOs.
- Overall accountable to ensure all operational related activities at the CMOs are conducted to meet Moderna's requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx).
- Maintain the integrity of the Master Supply Agreement ensuring alignment with Quality agreements and appropriate documents. Ensure contract terms are executed including issuance of purchase orders, forecasts and other deliveries.
- Ensure externally manufactured products are produced and stored according to the appropriate documentation in order to obtain the required quality.
- Approve instructions relating to external production operations and ensure their strict implementation by the CMOs
- Ensure in collaboration with quality and technical development that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna's requirements.
- Coordinate and perform the reviews for process performance at CMOs.
- Monitor Key Performance Indicators of CMOs.
- Support preparation of periodic business and operations review meetings.
- Drive and implement agreed continuous improvements at CMOs.
- Coordinate reviews and approvals of various documentations from CMOs.
- In collaboration with Quality and Technical Development coordinate investigations and troubleshooting efforts at CMOs
- Write or revise the appropriate GMP documentations.
- Frequently visit and maintain presence at the external partners' sites and build strong interdependent relationship with the Project Management Counterparts in order to assess the as is state & risks for action-oriented improvement plans.
- Performs other administrative/managerial duties as required.
Here's What You'll Bring to the Table:
- Bachelor's degree, in the Engineering or Sciences and 10+ years of industry experience or MS with 8+ years.
- Adapts departmental plans and priorities to address resource and operational challenges
- Requires comprehensive understanding of concepts and principles within own discipline and knowledge of others
- Outstanding communication skills (verbal and written) to collaborate with senior CMC Management in a dynamic, cross-functional matrix environment - you are outgoing, communicative, and seek to build relationships on a daily basis
- Well organized - a natural ability to be organized in how you think, communicate and conduct your work
- You drive for results - you set a high bar for yourself and others
- Good critical thinker that can anticipate the needed next step and therefore can work independently
- A curious mindset that allows you to constantly learn and challenge the status quo
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.