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Associate Director, CMC Project Management - Cell & Genetic Therapies

Hampton Research

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Boston, MA
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Job Description

As posted by the hiring company

Job Overview:

Job Description

General Summary:

Vertex has established a new research site in the Boston Seaport where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies, and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

VCGT is looking for an Associate Director Technical Project Manager for Hemoglobinopathies. The role will be responsible for managing the technical development plan and CMC department interfaces as part of the CMC Program Management team. The AD Technical Project Manager will work closely with the CMC (e.g., Analytical Development, Process Development), Clinical, Commercial Mfg & Supply Chain, Regulatory and Quality teams to meet program milestones.

Key Duties and Responsibilities:

  • Independently leads CMC teams on multiple development projects and operational workstreams
  • Works closely with the CMC Project Lead and team to align VCGT CMC goals and strategy with those of the Vertex Project Team and Disease Strategy Team
  • Conducts complex scenario planning to proactively provide analysis and recommendations on alternative development plans, along with the associated assumptions and risks
  • Effectively crafts dashboards to summarize key information such as program progress, timeline updates, and risk/opportunity assessments for routine and ad-hoc presentations to management
  • Develops and maintains project budgets, and is accountable for understanding and communicating forecast variance, risks and opportunities
  • Compiles succinct reports and prepares minutes for select internal and external meetings; methodically tracks all action items, and finds new ways to stay abreast of these multi-dimensional tasks
  • Maintains frequent communication with the network of cross-functional internal and external stakeholders so that all parties are aware of current program status, issues, contingencies, and milestones
  • Contributes to the best practices of project management to support the continued success and evolution of the department

Knowledge and Skills:

  • Highly skilled at enabling goals of projects and effectively moving projects forward
  • Significant experience in managing complex project teams and personnel; highly skilled at coaching and mentoring other professionals, maintaining procedural and ethical standards and cultivating healthy team morale
  • Highly effective communicator (verbal and written) within all levels of the department and cross functionally throughout the organization; communicates complex ideas across project boundaries, gaining alignment and persuading others to take action or adopt a different point of view
  • Able to manage concurrent projects effectively, ensuring alignment with corporate goals

Education and Experience:

  • Typically requires a bachelor's degree in a scientific or project management discipline, and 8+ years of experience or e equivalent combination of education and experience
  • Strong understanding of the drug development process and GxP

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.