Oversee and support clinical product manufacturing for cell therapy according to cGMP standards Drive more efficient technology transfer and final process development at CDMOs by providing direct oversight . Review, revise and approve controlled documentation including SOPs and Batch Records for manufacturing Ensure cGMP compliance through manufacturing oversight , tracki

Vertex has established a new research site in 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, D

Manage and develop a high performing team with focus on team diversity, engagement, and professional development. Collaborate across functions to create and drive execution of the Type 1 Diabetes (T1D) technical agenda, which details the projects and process development / improvements required to achieve strategic goals. Support the establishment of network strategies for

Represent the MSAT function in cross functional teams as a materials science technical subject matter expert for single use systems, cell culture media, and/or small/large molecule raw materials. Support and champion continuous improvement and technical innovation within the VCGT network with respect to raw materials. Establish procedures and business processes to conduct

Provides technical support on Packaging processes to Package Engineering and cross functional teams Author and/or review validation and change control documents such as master batch records, protocols, reports and change requests. Experience in software systems for validation protocols, change controls, CAPAs and Deviations. Experience with common primary, secondary, and

Provides leadership and oversight of DASH/Disease area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre FIH activities, key benefit risk assessment, and providing strategy for DSTs to meet goals and objectives. Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in acco

Provides leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre FIH activities, benefit risk assessment, and strategy for DSTs. Coordinates and oversees safety signals detection, in accordance with Vertex signal detection practices. Collaborates with Clinical Leaders to develop and implement appropriate Risk Management p

The Associate Director (AD) of Portfolio and Program Management (PPM) sits within the COO's organization at Vertex and leads assets from development through commercialization. In this role, the AD will partner with program leads and cross functional teams to establish cross functional plans and ensure execution against program goals and strategy. Key Duties and Responsibi

1. Develops and fosters effective and trusting relationships with Thought Leaders and identifies and engages other appropriate (allied) HCPs and other stakeholders involved in clinical practice decision making with regards to managing conditions associated with pain, resulting in scientific engagement with a large network of stakeholders involved in affecting care of pati

1. Develops and fosters effective and trusting relationships with Thought Leaders and identifies and engages other appropriate (allied) HCPs and other stakeholders involved in clinical practice decision making with regards to managing conditions associated with pain, resulting in scientific engagement with a large network of stakeholders involved in affecting care of pati

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria

The GMP Quality Operations Director serves as a Quality leader in the areas of process validation, and equipment validation in oral solid dosage form. The Director is also responsible for managing multiple department activities with a high degree of independence while providing oversight of the development, implementation, and maintenance of relevant quality initiatives i

The Training Associate Director is responsible for supporting the oversight of all Training related activities within the Global Regulatory Affairs organization. This role will work to create, curate, and deliver top notch learning experiences including both technical and professional development for the team. The Training Associate Director will report directly to the Se

The Vendor Management Associate Director oversees all vendor management activities for Global Regulatory Affairs, including vendor governance, vendor relationship management, performance management, and new vendor selection process. This role will serve as the key interface between Regulatory functional leaders and departmental vendors. Key Duties and Responsibilities Par