The Director / Associate Director, CMC Project Management will work closely with technical and functional area members, vendors, and contract laboratories to develop CMC plan, coordinate and track the progress of CMC plan as established by defined milestones and objectives.
• Work with team leaders to set agendas, plan team strategies, develop CMC plan, coordinate activities and decision making.
• Coordinate meeting logistics including scheduling the meetings, sending out the agendas, writing and distributing minutes, tracking goals and action items, collecting meeting materials from line functions and distributing them to the team before the meeting.
• Manage team documentation. Coordinate the collection of CMC material needs, including all cross functional sampling/testing needs for clinical supplies.
• Identify solutions for project management continuous improvement opportunities across CMC teams and manage execution of the agreed upon strategies.
• Communicate effectively to stakeholders. Represent the CMC Team when communicating externally.
• Creates and maintains detailed CMC project plan to ensure clarity of deliverables and timing.
• Facilitates coordination of deliverables for assigned CMC projects.
• Tracks project tasks and efforts associated with process development, analytical development, pharmaceutical development, manufacturing, quality, supply chain, and regulatory-CMC.
• Facilitates assessment of critical path issues and areas of risk, develop risk mitigation plans, and assemble supporting data or ?information to assist in decision making by the project team.
• Assesses CMC project issues and develops solutions to increase productivity and quality milestones and objectives.
• Provides support to Management in assessing resource needs to achieve timelines and quality milestones.
• Works with the team leader to identify and resolve any team and individual performance issues.
• Identifies and implements best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.
• Develops tools and mechanisms for monitoring progress and problem solving with CMC project and functional area managers.
• Publishes clear and concise meeting agendas, notes and action items.
• Provides feedback to management of project progress / scope changes / new business opportunities.
• Cultivates effective communication, cooperation and trust within team members and stakeholders.
• Develops and maintains a document archiving system for the purpose of efficient communication between stakeholders.
Why join Moderna Therapeutics?
Moderna Therapeutics is pioneering messenger RNA therapeutics™, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn active intracellularly or secreted. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate including 200 patent applications with 10,000 claims ranging from novel nucleotide chemistries to specific drug compositions. The company plans to develop and commercialize its innovative mRNA drugs—initially for rare diseases and oncology—while partnering drug candidates in other therapeutic areas in order to rapidly deliver this innovation to patients.
Based in Cambridge, Massachusetts, Moderna is privately held and was founded in 2010 by Flagship VentureLabs in association with leading scientists from Harvard University and Massachusetts Institute of Technology.
Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).
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.
Visit http://modernatx.com/revolution to apply.
• Degree in a scientific discipline with a minimum of 10 years’ experience in a pharmaceutical or biotechnology environment which includes at least 2 years managing projects in CMC areas for biologics.
• Demonstrated understanding of the drug development process from research through a commercial product including an understanding of the interdependencies of functional groups.
• CMC project management experience, PMP certification, advanced degree or MBA a plus.
• Proficient in relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to general knowledge with shared work environments. Experience with Visio and Milestones a plus.
• Preferred candidate will have experience in GMP production, process development, scale-up engineering, analytical method development, formulation, and 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.
• Works well independently using strong organizational, project and time management skills.
• Effective verbal communication skills and excellent written skills. Experience writing scientific, quality and/or regulatory documents highly desirable.
• Building strategic working relationships.
• Building trust.
• Delegating responsibility.