Job Description
General Summary:
This Commercial Manufacturing and Supply Chain (CMSC) Director Project Management, Povetacicept (POVE) will be responsible for facilitating the cross-functional project teams executing our CMC and manufacturing strategies within Vertex's newly formed POVE portfolio. Povetacicept is a Phase 3 ready asset that is potentially best-in-class asset for IgA nephropathy (IgAN), a severe autoimmune disease, with potential benefit for other autoimmune diseases of the kidney and blood. The position will work with the CMSC and CMC leads and interface directly with CDMOs and internal cross-functional teams. The position will track and report project scope, timeline, and milestone status associated with technical transfer (analytical/process), product manufacturing and testing, process validation, inspection readiness, capacity planning, product launch, lifecycle management and regulatory strategies and commitments. This is an exciting and visible role for a highly qualified and motivated individual.
The successful candidate will be detail-driven and have a proven track record in managing and driving project success within the biotech industry. We are seeking an individual with a technical background, solid working knowledge of GMPs, understanding of the drug development pathway through commercialization, experience interacting with external manufacturers/service providers, and willingness to pivot as priorities change. A strong understanding of risk management will be an asset. The successful candidate will have excellent communication skills, written and verbal, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams.
Key Duties and Responsibilities:
Partner closely with Strategic Product Leader, functional area leads to distill complex strategies and develop and maintain integrated CMSC program plans. Identify/communicate interdependencies as well as critical path activities for the project(s).
Track and monitor key milestones and decision points and work with project team members to meet commitments and drive delivery of project objectives.
Engage directly with CDMOs to prepare detailed timelines with clear deliverables and accountabilities; work with CDMO to ensure risks identified and mitigated, and escalations occur in timely fashion to enable on time delivery.
Effectively communicate with senior leadership, team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects. Ensure relevant R&D updates are included in communications.
Support and enable successful integration of Vertex and Alpine CMC and CMSC teams (Vertex's newly acquired company) through the POVE team.
Build and maintain effective program tools, including fully integrated CMSC program plan and timeline, key assumptions, milestones and decisions, risk register, after action review database, and cross-functional knowledge management materials.
Identify meaningful KPIs and build program dashboard for key communications across all impacted functions.
Assist in creation of lifecycle management plan, with a focus on strategic prioritization to ensure success in meeting patient needs, overcoming supply challenges and reducing COGS.
Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable.
Education and Experience:
Bachelor's degree in engineering, life sciences or related field. Advanced degree (MS, PhD or MBA) and/or PMP Certification preferred.
Requires 10 years of experience in the biopharmaceutical industry. Previous experience in supply chain, technical operations and biologics preferred.
A minimum of 5 years of experience in project management of pharmaceutical products.
Experience interacting with and/or managing CDMOs/service providers.
Working knowledge of biotechnology, GMPs, and drug development lifecycle.
Ability to work effectively in cross-functional, matrixed environment, proactively prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively.
Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools a plus (e.g. Smartsheet, OnePager, etc.).
Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
Experience with regulatory submissions, manufacturing or QC/QA experience a plus.
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Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
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.
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 ******
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