Commercial Manufacturing and Supply Chain Senior Project Manager (Late Stage Biologics)

This job is with Vertex Pharmaceuticals, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly.

Job Description

This Commercial Manufacturing and Supply Chain (CMSC) Senior Project Manager, Povetacicept (POVE) will be responsible for supporting the cross-functional project teams executing our CMC and manufacturing strategies within the Povetacicept 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, hybrid position requiring 3 day/week onsite.

Responsibilities

• The project manager will work in close partnership with Program manager and other Project Managers to ensure seamless execution of the program and project-level deliverables of a fast-paced, high-priority program
• Be the PM point of contact for assigned workstreams. Work collaboratively and maintain tight alignment to drive integrated execution
• Partner closely with functional area leads and CDMOs to develop, maintain and actively monitor detailed integrated project plans. Identify/communicate interdependencies as well as critical path activities for the project(s)
• Act as primary PM point of contact for assigned workstreams for internal stakeholders and external CDMOs
• Facilitating cross functional team meetings to ensure alignment; issue resolution by getting right stakeholders and decision makers in the room to facilitate prompt resolution and risk /mitigation management
• 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, 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 to ensure timely, transparent and open communication
• Assist in the creation and deployment of templates to manage team activities
  
  

Qualifications

• Bachelor's degree in engineering, life sciences or related field. Advanced degree (MS, PhD or MBA preferred) or PMP
• A minimum of 5 years of experience in the biopharmaceutical industry.
• A minimum of 3 years of experience in CMC project management of biopharmaceutical products
• Understanding of CMC requirements for all phases of clinical development and commercialization
• Highly agile, be able to pivot quickly as priorities shift or as new workstreams emerge
• Ability to work independently, cross functionally and collaboratively in a team
• Excellent planning and organization skills with ability to prioritize
• Experience interacting with and/or managing CDMOs/service providers.
• Working knowledge of biotechnology, GMPs, and drug development lifecycle.
• Previous experience in Biologics manufacturing including process validations/PPQ and commercialization preferred
• 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.
  
  

Pay Range

$132,000 - $198,000

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as:

• Hybrid: work remotely up to two days per week; or select
• 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 ApplicationAssistance@vrtx.com