This newly created role is an exciting opportunity to be an integral part of a growing legal team. The Sr. Counsel, Legal - Manufacturing and Supply Chain will be responsible for providing best in class legal support for our US Manufacturing and Technical Development teams as part of our Global TechOps Legal team. The successful candidate will play a critical role in building our manufacturing network to ensure continuity of supply across the company’s diverse pipeline of novel mRNA therapeutics and vaccines, including the Moderna’s personalized cancer vaccine which is currently in development. The successful candidate will have experience in managing the legal aspects of building out a commercial pharmaceutical manufacturing network and supply chain and supporting end-to-end operational activities from process development through GMP manufacture and distribution to end customers.
Here’s What You’ll Do
- Partner cross-functionally and collaborate with business and legal stakeholders acting as enterprise connector to ensure global excellence, consistency and compliance.
- Act as legal business partner to technical development, US manufacturing, US quality, engineering, supply chain and procurement teams and provide strategic guidance to ensure excellent execution.
- Become an instrumental contributor to the Global CMC Legal Team and help build and transform Moderna’s legal support for Technical Operations globally.
- Draft, negotiate and support contract implementation with third parties and complex construction projects, and support dispute resolution efforts as required.
- Provide strategic support on GxP and regulatory compliance topics, including interactions with health authorities globally as required.
- Drive best in class legal support for policies, processes, templates, governance principles and support structures as we grow and scale globally.
- Additional duties as may be assigned from time to time
Here’s What You’ll Need (Minimum Qualifications)
- J.D. from a national law school and admission to any state bar in the United States.
- Must be licensed to practice law in Massachusetts via the MA Board of Bar Overseers or licensed in at least 1 other jurisdiction.
- Minimum 7+ years’ experience in the biotechnology or pharmaceutical industry required.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
- Experience within a law firm and pharmaceutical/biotechnology company supporting manufacturing, engineering, construction, supply chain and quality preferred.
- Enthusiasm and a passion to enable an exciting new technology platform through successful launches of innovative mRNA-based medicines.
- Strong drafting and communication skills, and an ability to maintain a high level of attention to detail without losing sight of the big picture.
- Experience in a variety of contracting and transactional matters including drafting and negotiating manufacturing, distribution, construction, engineering, procurement, supply and quality agreements.
- Experience of the regulatory environment in which a global pharmaceutical company operates, including familiarity with GxP, trade compliance and pharmaceutical legal requirements.
- Commitment to client service, finding solutions, relationship building, continued learning, proactivity and confidentiality.
- Excellent interpersonal skills that are demonstrated by being articulate, direct and forthright, and serving as a collaborative and decisive team member and a strategic thinker with a broad perspective
- Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations
- Demonstrated ability to own projects and consistently meet tight timing requirements and high-quality standards
- Strong verbal and written communication skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization.
- Ability to handle confidential and proprietary information using impeccable discretion and judgment
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.