Manufacturing Technical Operations Project Manager

Daley And Associates, LLC; Boston (MA); On-site; USD 80,000 - 90,000; Part time

Job summary

Daley And Associates, LLC is seeking a Senior Manufacturing Technical Operations Project Manager to join a leading pharmaceutical company focused on cell and gene therapies. The role supports cross-functional project teams, change controls, and milestone tracking for a high-stakes program.

This 1-year contract, based in Boston, MA, requires extensive biopharma project management experience, strong communication skills, and proficiency with GMPs and regulatory controls.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• Minimum 8 years in biopharmaceutical industry.
• Minimum 6 years in project management for biopharma products.
• Knowledge of GMPs, regulatory requirements (FDA, EU GMP, ICH Q10).
• Experience with cell and gene therapy preferred.

Responsibilities

• Maintain and monitor integrated project plans.
• Identify interdependencies and critical-path activities.
• Track milestones and drive changes.
• Communicate status, risks, and mitigations with stakeholders.
• Organize team communications, agendas, minutes, risks and mitigations.
• Update project-status tools and risk registers.
• Develop PM tools/templates to support change-control activities.
• Adhere to SOPs and GxP requirements.

Skills

Project management

Cross-functional

GxP knowledge

Biopharma

Regulatory knowledge

Communication

Education

Bachelor's degree

Tools

Microsoft Project

Power BI

Smartsheet

SharePoint

Job description

Technical Operations ProjectManager

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

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