Vertex Pharmaceuticals
Commercial Manufacturing & Supply Chain Senior Project Manager
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Overview
This Commercial Manufacturing and Supply Chain (CMSC) Senior Project Manager will be responsible for supporting cross-functional project teams executing CMC and manufacturing strategies within the Povetacicept (POVE) program. The role will interface with CMSC and CMC leads, CDMOs, and internal cross-functional teams to track and report project scope, timeline, and milestone status related to technical transfer (analytical/process), regulatory strategies and commitments, product manufacturing, process validation, product testing, capacity planning, and external partner strategy. The successful candidate will be detail-driven with a proven track record in managing and driving project success in the biotech industry. A technical background, working knowledge of GMPs, understanding of the drug development pathway through commercialization, experience interacting with external manufacturers/service providers, and adaptability to changing priorities are required. Knowledge of cell/gene therapy methodologies and risk management is an asset. Strong written and verbal communication, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams are essential. This is a Boston-based position requiring 3 days per week onsite. Responsibilities
Partner closely with functional area leads and CDMOs to develop, maintain and monitor integrated project plans; identify and communicate interdependencies and critical path activities. Track and monitor key milestones and decision points and drive delivery of project objectives. Effectively communicate with internal and external team members and stakeholders on status, objectives, risks, and mitigation plans. Organize and maintain team communications including meeting agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies using program management tools. Update and maintain project status tools such as action logs, risk registers, budgets, and dashboards. Assist in the creation and deployment of templates to manage team activities. 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. Minimum of 6 years of experience in the biopharmaceutical industry. Experience in biologics manufacturing and managing external CDMOs. Minimum of 3 years of project management experience for biopharmaceutical products. Experience interacting with and/or managing CMOs/service providers. Working knowledge of biotechnology, GMPs, and the drug development lifecycle. Ability to work effectively in a cross-functional, matrixed environment and manage multiple priorities. Proficiency with Microsoft Project, PowerPoint, SharePoint, Word, Excel, Outlook; experience with tools such as Smartsheet or Power BI is a plus. Excellent oral and written communication, including presentation and facilitation skills. Strong analytical, problem-solving and critical-thinking skills with attention to detail and big-picture perspective. Experience with regulatory submissions or manufacturing/QC/QA is a plus. Pay Range: $136,400 - $204,600 Disclosures
Disclosure Statement:
The range provided is based on a reasonable estimate for base salary at the time of posting. Roles may be eligible for annual bonus and equity awards. Actual salary will depend on skills, experience and other factors permitted by law. Flex Designation:
Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as Hybrid (remote up to two days per week) or On-Site (five days per week on-site with ad hoc flexibility). Note: Flex status is subject to Vertex policy and may change. Company Information:
Vertex is a global biotechnology company focused on scientific innovation. Vertex is an equal opportunity employer and E-Verify participant. Reasonable accommodations will be provided for qualified individuals with known disabilities, in accordance with applicable law. If you require an accommodation during the hiring process, please contact the recruiter or Talent Acquisition at ApplicationAssistance@vrtx.com. #J-18808-Ljbffr
This Commercial Manufacturing and Supply Chain (CMSC) Senior Project Manager will be responsible for supporting cross-functional project teams executing CMC and manufacturing strategies within the Povetacicept (POVE) program. The role will interface with CMSC and CMC leads, CDMOs, and internal cross-functional teams to track and report project scope, timeline, and milestone status related to technical transfer (analytical/process), regulatory strategies and commitments, product manufacturing, process validation, product testing, capacity planning, and external partner strategy. The successful candidate will be detail-driven with a proven track record in managing and driving project success in the biotech industry. A technical background, working knowledge of GMPs, understanding of the drug development pathway through commercialization, experience interacting with external manufacturers/service providers, and adaptability to changing priorities are required. Knowledge of cell/gene therapy methodologies and risk management is an asset. Strong written and verbal communication, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams are essential. This is a Boston-based position requiring 3 days per week onsite. Responsibilities
Partner closely with functional area leads and CDMOs to develop, maintain and monitor integrated project plans; identify and communicate interdependencies and critical path activities. Track and monitor key milestones and decision points and drive delivery of project objectives. Effectively communicate with internal and external team members and stakeholders on status, objectives, risks, and mitigation plans. Organize and maintain team communications including meeting agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies using program management tools. Update and maintain project status tools such as action logs, risk registers, budgets, and dashboards. Assist in the creation and deployment of templates to manage team activities. 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. Minimum of 6 years of experience in the biopharmaceutical industry. Experience in biologics manufacturing and managing external CDMOs. Minimum of 3 years of project management experience for biopharmaceutical products. Experience interacting with and/or managing CMOs/service providers. Working knowledge of biotechnology, GMPs, and the drug development lifecycle. Ability to work effectively in a cross-functional, matrixed environment and manage multiple priorities. Proficiency with Microsoft Project, PowerPoint, SharePoint, Word, Excel, Outlook; experience with tools such as Smartsheet or Power BI is a plus. Excellent oral and written communication, including presentation and facilitation skills. Strong analytical, problem-solving and critical-thinking skills with attention to detail and big-picture perspective. Experience with regulatory submissions or manufacturing/QC/QA is a plus. Pay Range: $136,400 - $204,600 Disclosures
Disclosure Statement:
The range provided is based on a reasonable estimate for base salary at the time of posting. Roles may be eligible for annual bonus and equity awards. Actual salary will depend on skills, experience and other factors permitted by law. Flex Designation:
Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as Hybrid (remote up to two days per week) or On-Site (five days per week on-site with ad hoc flexibility). Note: Flex status is subject to Vertex policy and may change. Company Information:
Vertex is a global biotechnology company focused on scientific innovation. Vertex is an equal opportunity employer and E-Verify participant. Reasonable accommodations will be provided for qualified individuals with known disabilities, in accordance with applicable law. If you require an accommodation during the hiring process, please contact the recruiter or Talent Acquisition at ApplicationAssistance@vrtx.com. #J-18808-Ljbffr