CHANGE CONTROL PROJECT MANAGER

Intone Networks Inc.; Boston, Northern (MA, KY); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Intone Networks Inc. seeks a Change Control Project Manager for a 6+ month contract in Boston, MA to support cross-functional teams executing change controls within a cell and gene therapy program.

You will track scope, timelines, and milestone status while communicating updates and risks. The ideal candidate has a detail-driven approach, 8+ years in biopharma project management, strong GMP knowledge, and understanding of the drug development pathway through commercialization.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• Minimum 8 years of experience in the biopharmaceutical industry.
• Minimum 6 years of experience in project management of biopharmaceutical products.
• Working knowledge of biotechnology, GMPs, and the drug development lifecycle.
• Ability to work effectively in cross-functional, matrixed environments with multiple priorities.
• Expertise in Microsoft Office suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook).
• Excellent oral and written communication skills, including presentation and facilitation capabilities.
• Strong analytical, problem-solving, and critical thinking skills.
• Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10).
• Understanding of risk assessment.

Responsibilities

• Partner closely with functional area leads to maintain and monitor integrated project plans.
• Track and monitor milestones and decision points; drive completion of changes.
• Communicate with team members and stakeholders regarding project status, risks, and mitigation plans.
• Organize and maintain team communications including meeting agendas, minutes, task lists, and risk analyses.
• Update and maintain project status tools, such as action logs and risk registers.
• Develop and deliver project management tools and templates for change control activities.
• Perform duties within SOPs and GxP requirements where applicable.

Skills

Cross-functional coordination

Communication

Project management

Regulatory knowledge

GxP

MS Office

Education

Bachelor's degree in engineering, life sciences, or related field

Tools

Microsoft Project

SharePoint

PowerPoint

Word/Excel/Outlook

Job description

We are seeking a Change Control Project Manager for a 6+ month contract position based in Boston, Massachusetts. In this role, you will support cross-functional project teams executing change controls within a cell and gene therapy program, tracking and reporting on project scope, timeline, and milestone status. You will need to demonstrate a detail-driven approach, a proven track record of managing project success in the biotech industry, a strong technical background, solid working knowledge of GMPs, and an understanding of the drug development pathway through commercialization.

Responsibilities

• Partner closely with functional area leads to maintain and actively monitor integrated project plans, identifying and communicating interdependencies and critical path activities.
• Track and monitor key milestones and decision points, working with project team members to drive completion of changes.
• Communicate effectively with internal team members and key stakeholders regarding project status, objectives, risks, and mitigation plans associated with change control projects.
• Organize and maintain team communications, including meeting agendas, minutes, task lists, and risk analyses and mitigation strategies.
• Update and maintain project status tools, such as project action logs and risk registers.
• Develop and deliver project management tools and templates to manage change control team activities.
• Perform duties consistently within established SOPs and in accordance with GxP requirements, where applicable.

Qualifications

• Required
  • Bachelor's degree in engineering, life sciences, or related field.
  • Minimum 8 years of experience in the biopharmaceutical industry.
  • Minimum 6 years of experience in project management of biopharmaceutical products.
  • Working knowledge of biotechnology, GMPs, and the drug development lifecycle.
  • Ability to work effectively in cross-functional, matrixed environments, prioritizing and managing multiple tasks simultaneously while integrating cross-functional issues and balancing competing priorities.
  • Expertise in Microsoft Office suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook).
  • Excellent oral and written communication skills, including presentation and facilitation capabilities, to effectively communicate updates and issues across organizational levels.
  • Strong analytical, problem-solving, and critical thinking skills with the ability to combine attention to detail with big-picture perspective.
  • Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10).
  • Understanding of risk assessment.
• Preferred
  • Knowledge and/or experience with cell and gene therapy methodologies.
  • Experience with additional project management tools (e.g., Smartsheet, Power BI).