Commercial Manufacturing & Supply Chain Senior Project Manager

Job Description

This Commercial Manufacturing and Supply Chain (CMSC) Senior Project Manager will be responsible for supporting the cross-functional project teams executing our CMC and manufacturing strategies within our Povetacicept (POVE) program. 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/milestone status associated with technical transfer (analytical/process), regulatory strategies and commitments, product manufacturing, process validation, product testing, capacity planning, and external partner strategy. 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. Some knowledge and/or experience with cell / gene therapy methodologies and 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.

This is a Boston based position requiring 3 days/week onsite.

RESPONSIBILITIES

• Partner closely with functional area leads and CDMOs to develop, maintain and actively monitor integrated project 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 drive delivery of project objectives
• Effectively communicate with internal and external team members, and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects
• Organize and maintain team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses/mitigation strategies using Program Management preferred technologies
• Update and maintain project status tools, such as a project action log, risk register, budget and reporting dashboards
• Assist in the creation and deployment of templates to manage team activities
• Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable

QUALIFICATIONS

• Bachelor's degree in engineering, life sciences or related field. Advanced degree (MS, PhD or MBA preferred).
• A minimum of 6 years of experience in the biopharmaceutical industry.
• Previous experience in Biologics manufacturing and managing external CDMOs.
• A minimum of 3 years of experience in project management of biopharmaceutical products
• Experience interacting with and/or managing CMOs/service providers.
• Working knowledge of biotechnology, GMPs, and drug development lifecycle.
• Ability to work effectively in cross-functional, matrixed environment, 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, ThinkCell, Power BI, 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:

Flex Eligibility Status:

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 ApplicationAssistance@vrtx.com