Company Overview

Prime Medicine was founded to bring the promise of gene editing to patients. We use Prime Editing, a next-generation technology that can “search and replace” to restore normal genetic function almost anywhere in the genome. Prime Editing searches to find the precise place in the genome to edit and replaces the segment of faulty DNA with a correct copy of DNA.  A single Prime Editor can correct the individual mutations found across patients, meaning Prime Editing can potentially address more than 90 percent of known disease-causing genetic mutations.  

We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefit to patients.  Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. Realizing the promise of Prime Editing requires a talented team with diversity of viewpoints and expertise. We’re building a group of dedicated, scientifically curious individuals who are passionate about helping patients live longer, healthier lives.

Position Overview:

 The Sr. Director of CMC Project, Portfolio Management, and Team Leadership will be a key partner reporting to the CTO and supporting the TDO LT by managing Prime’s CMC product portfolio.  The incumbent will build out the CMC Team system including establishing effective and fit-for-purpose strategy/science reviews.  The leader will mentor CMC leaders, establish ways for sharing best practices, and help to define and drive implementation of manufacturing and analytical technology platforms.  Also, will provide CMC project portfolio information to enable strategic decision making.  Partner closely with those in Program Management to establish aligned ways of working with respect to collaboration, communication, innovation and problem-solving cross-functionally (with Research, Clinical, Non-clinical teams, Regulatory, Finance and other functions and within Tech Dev and Ops to advance the portfolio programs), and to educate on CMC strategy.  Contribute to Prime’s Cell Therapy programs by sharing expertise and knowledge of operations, analytics, and logistics.  

Primary Responsibilities:

  • Build and define our CMC teams’ ways of working to effectively launch, develop, train, and manage CMC teams. Provide team leaders with education, skills, and resources to develop the right CMC strategies, execute, and conduct opportunities for lessons learned, sharing across programs, and continuous improvement.  Provide strategic CMC portfolio perspective to help CMC teams and functions to deliver and achieve program, R&D/TDO and company goals.
  • Partner with Program Management and build connected CMC team system to develop our CMC team leaders (part time model) and create learning opportunities to share strategies and best practices across programs. Partner with and mentor as needed the CMC team leaders and project managers.
  • Oversees the management of Prime’s entire CMC portfolio and provide strategic oversight with the objective of timely and critical CMC data review, prioritization, decision-making, resource allocation, identification of critical path activities, establish risk mitigation plans, and effective communication. Maintains and align the portfolio of CMC projects across the company to support Tech Dev and Ops functional leadership in decision making, and allocation of resources.  Proactively manage project risks and mitigation plans
  • Contribute to data and knowledge management strategy by providing CMC projects perspective to enable automation of documentation needs, and visualization of data and information.
  • Establish expectations for seamless interfaces, coordination, and collaboration with other teams to accomplish company goals
  • Directly manage one or more CMC teams as CMC Lead as needed
  • Manage HSC cell processing team, and share knowledge, expertise, and assume functional accountability to implement the manufacturing technology platform for HSC cell processing.
  • Hold CMC teams and respective functions accountable for generating all CMC documents, data needed and regulatory sections supporting Quality section of IND/CTAs.

 Basic Qualifications:

  • PhD with 10+ years or MS with 15+ years of relevant experience in a bio/pharma company. Degree in Chemistry, Bio/Chemical Engineering, Bioengineering, Pharmaceutical sciences, or related field is preferred
  • Significant experience in all aspects of process and/or analytical development, CMC strategy development, and CMC project and portfolio management to support advanced therapeutic drug development (Cell and gene therapies)- late-stage CMC development/commercialization launch experience preferred; substantial experience managing multidisciplinary teams and CMC portfolio required
  • Previous experience serving as a CMC or project team leader achieving milestone of IND filing required or significant changes for INDa (CTAa), with BLA approval experience preferred.
  • Understanding of regulatory requirements for development of therapeutic drugs or vaccines including requirements for product comparability; experienced in supporting multiple regulatory filings (e.g., INDs, BLAs, etc.), and interactions with US and foreign regulatory agencies
  • Demonstrated capability to create an environment to foster innovation of new manufacturing technologies, and approaches to new/high throughput process development
  • Proven track record in scientific and people leadership; strong mentoring skills and developing staff
  • Eager to work collaboratively in a fast-paced, dynamic, entrepreneurial, and team-based setting
  • Excellent communication skills, with the ability to influence and engage across all levels of the corporation and with external stakeholders; strong interpersonal skills/diplomacy, and negotiation skills
  • Develops a powerful sense of shared purpose and motivates teams to solve problems in a way that consistently meets or exceeds goals, encouraging innovation, and creating better ways for doing things
  • Embraces the principles of equality, diversity, and inclusion and creates an inclusive and safe environment enabling all employees contribute to their full potential

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.

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