Associate Director, CMC Project Management
The Associate Director, CMC Project Management will report to the Head of CMC Project Management and will work closely with technical and functional area members, vendors, and contract laboratories to develop CMC plans to progress mRNA therapeutics from bench to clinic, coordinate and track the progress of CMC plans as established by defined milestones and objectives.
Here's What You'll Do:
- Serve as an integral member of project teams to progress CMC activities and generate/execute CMC timelines.
- Work with the nonclinical and clinical teams to project drug needs, drug presentation and batch requirements.
- Work with Supply Chain to manage manufacturing strategy and scheduling.
- Coordinate meeting logistics including scheduling the meetings, sending out the agendas, running meetings, writing and distributing minutes, tracking goals and action items.
- Manage team documentation.
- Communicate effectively to stakeholders including internal project teams and external partners.
- Create and maintain detailed CMC project plans to ensure clarity of deliverables and timing.
- Track project tasks and efforts associated with process development, analytical development, pharmaceutical development, manufacturing, quality and supply chain.
- Provide support to Management in assessing resource needs to achieve timelines and quality milestones.
- Identify and implement best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.
- Develop tools and mechanisms for monitoring progress and problem solving with CMC project and functional area managers.
- Publish clear and concise meeting agendas, notes and action items.
Here's What You'll Bring to the Table:
- Bachelor's Degree in a scientific discipline with a minimum of 10+ years of experience, MS with 8+ years or PhD with 5+ years in a pharmaceutical or biotechnology environment managing projects in CMC areas.
- Demonstrated understanding of the drug development process from research through Phase 2 including an understanding of the interdependencies of functional groups.
- Proficient in relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to general knowledge with shared work environments.
- Experience in GMP production, process development, scale-up engineering, analytical method development, formulation, and/or characterization.
- Demonstrated experience managing interdisciplinary development teams; exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.
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.