The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriatel

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life shortening genetic diseases cystic fibrosis, sickle cell disease and transfusion dependent beta thalassemia and continues to advance

Vertex's Data, Technology and Engineering (DTE) team is seeking a Manufacturing and Supply Chain (MSC) Technology Portfolio Manager to join our Project Management and Strategic Operations group. Project Management and Strategic Operations is charged with streamlining and simplifying the work of our data and technology teams and ensuring the successful deployment of new te

Provides comprehensive expertise and guidance in the Therapeutic Area and Vertex drugs Develops and maintains professional relationships with local Health Care Professionals, and with local Professional Societies and Patient Advocacy groups. Establishes relationships with Thought Leaders to expand research opportunities for Vertex and develops, at local level, advisory, c

Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, documents to support meetings with regulatory agencies, and sections of marketing authorization applications) in partnership with key stakeholders Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple

The Executive Director, Pain Global Strategy will have global responsibility to build the Global Medical strategy for Pain assets. Communicate the Global Medical strategy to partner functions for further strategic and tactical guidance. Execute the Global components of the medical strategy plan. Partner with Clinical Development, HEOR, RWE, Regional Medical Affairs and pa

CMC Project Leadership Partners with Biopharmaceutical Sciences LT members, and CMC PLs to ensure all projects have integrated CMC development plans, aligned with Disease Area Team's strategic program goals and objectives Leads a team of dedicated CMC Project Leaders, each accountable for ensuring the integrated development and on schedule execution of one or more CMC Pro

The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition. This is an on site position on the 2nd shift. KEY DUTIES AND RESPONSIBILITIES Review batch data,

Maintain a high level of productivity in the laboratory setting Develops and executes clear synthetic routes using state of the art synthetic methodologies Primarily responsible for executing organic syntheses in a timely, efficient, and independent manner Create and interpret SAR with a clear understanding of the biological data Organize and triage efforts to stay consis

Oversee material requirements and lead the device raw material planning process for the providence, RI site for BOM and non BOM materials. Partner with CMC, Procurement and Strategic Sourcing to ensure supply and solve supplier and materials related issues. Manage direct and indirect materials for manufacturing activities, as well as materials for packaging/labeling and s

Responsible for all aspects of warehouse and materials management functions for the GMP/non GMP materials within the Boston and Cambridge warehouses (internal and external). Coach and lead a team of material handlers. Design organizational structure as needed. Act as Business Process Owner for materials management, collaborating with other Material Management leads within

Provide technical input into environmental/facility/process monitoring program deviations and contamination events to determine impact to batch disposition and design/implement effective corrective and preventative actions to prevent future disruptions. Strong collaboration in the resolution of manufacturing investigations related to aseptic control events Support the des

Develop engagement strategy and account plans to ensure success with target IDNs, GPOs and GPO aggregate accounts Engage with IDN, GPO and GPO aggregate account leadership, formulary decision makers, and population health stakeholders to ensure timely access and contracting, support product uptake, drive systemic change, and pursue creative partnerships, as appropriate Co

Develop engagement strategy and account plans to ensure success with target IDNs, GPOs and GPO aggregate accounts Engage with IDN, GPO and GPO aggregate account leadership, formulary decision makers, and population health stakeholders to ensure timely access and contracting, support product uptake, drive systemic change, and pursue creative partnerships, as appropriate Co

Develop engagement strategy and account plans to ensure success with target IDNs, GPOs and GPO aggregate accounts Engage with IDN, GPO and GPO aggregate account leadership, formulary decision makers, and population health stakeholders to ensure timely access and contracting, support product uptake, drive systemic change, and pursue creative partnerships, as appropriate Co