Manufacturing Technical Operations Project Manager

Technical Operations Project Manager

Our client, a leading pharmaceutical company focused on discovering, developing, manufacturing, and commercializing therapeutic treatments, is currently seeking a Senior Manufacturing Technical Operations Project Manager to join their team. This person will support cross-functional project teams executing change controls and tracking project scope, timelines, and milestone status for a cell and gene therapy program. This is a 1-year contract position with the potential to extend.

Responsibilities

• Partner closely with functional area leads to maintain and actively monitor integrated project plans.
• Identify and communicate interdependencies and critical-path activities for assigned projects.
• Track key milestones and decision points, and work with project team members to drive the 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, including project action logs and risk registers.
• Develop and deliver project-management tools and templates to support change-control team activities.
• Consistently perform duties within established SOPs and in accordance with applicable GxP requirements.

Qualifications

• Bachelor's degree in engineering, life sciences, or a related field.
• A minimum of eight years of experience in the biopharmaceutical industry.
• A minimum of six years of project-management experience involving biopharmaceutical products.
• Working knowledge of biotechnology, GMPs, and the drug-development lifecycle.
• Ability to work effectively in a cross-functional, matrixed environment; prioritize and manage multiple tasks simultaneously; integrate cross-functional issues; and balance competing priorities.
• Expertise in the Microsoft suite, including Project, PowerPoint, SharePoint, Word, Excel, and Outlook.
• Experience with additional project-management tools, such as Smartsheet and Power BI, is a plus.
• Excellent oral and written communication skills, including presentation and facilitation skills, with the ability to communicate key updates and issues across all levels of the organization.
• Strong analytical, problem-solving, and critical-thinking skills, including the ability to combine attention to detail with a big-picture perspective.
• Strong understanding of applicable regulatory requirements, including FDA requirements, 21 CFR Part 211, EU GMP, and ICH Q10.
• Must be detail-driven and have a proven history of managing and driving project success within the biotech industry.
• Must have a technical background, solid working knowledge of GMPs, an understanding of the drug development pathway through commercialization, and a willingness to pivot as priorities change.
• Knowledge or experience with cell and gene therapy methodologies preferred
• A strong understanding of risk management will be an asset.

Pay Range: $58.00 – $65.00/hr

If you are interested in this position, please send your resume to apowell@daleyaa.com

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