Manager, Project Management - MS & T Support

Description

Job Summary:

The Manager, Project Management is responsible for leading and coordinating project management activities that support post‑commercial launch and product lifecycle management projects at the commercial manufacturing site. This role partners closely with MS&T, Manufacturing Operations, Quality, Engineering, Supply Chain, and Site Leadership to ensure effective execution of lifecycle changes, process optimization initiatives, validation activities, and supply continuity projects.

The role ensures projects are planned, governed, and executed in compliance with GMP and site quality systems while minimizing risk, maintaining commercial supply, and enabling continuous improvement of commercial manufacturing processes.

Job Responsibilities

• Lead and manage post‑commercial launch and product lifecycle MS&T projects, including post‑approval process changes, continuous improvement initiatives, yield, robustness, and cost optimization efforts, and post‑launch technical remediation activities.
• Develop and maintain integrated project plans, timelines, milestones, and dependencies that support manufacturing stability and effective lifecycle execution.
• Serve as the central point of coordination for MS&T‑led lifecycle initiatives, partnering closely with Manufacturing Operations, Quality Assurance and Quality Control, Engineering and Automation, and Supply Chain, Planning, and Scheduling.
• Drive cross‑functional alignment to ensure lifecycle project execution is integrated with routine commercial manufacturing and production schedules.
• Plan, coordinate, and manage execution of engineering, validation, and re‑validation activities, CPV‑related initiatives, and change control–driven lifecycle workstreams.
• Ensure operational, quality, and technical readiness for lifecycle changes by confirming availability and alignment of approved change controls, validation strategies and protocols, resource capacity, and production timing.
• Implement standardized project management tools and governance to track progress against milestones, manage interdependencies, identify, assess, and mitigate technical, compliance, and supply risks.
• Proactively escalate risks, issues, and decision needs that may impact product quality, regulatory compliance, manufacturing performance, or supply continuity.
• Prepare and deliver regular project status updates to site and functional leadership, clearly communicating progress versus plan, key risks and mitigations, decision points, and potential impacts to operations and supply.
• Document meeting minutes, action items, and key decisions to ensure transparency, accountability, and effective execution.
• Ensure all project activities are executed in compliance with site quality systems and applicable GMP requirements.
• Support MS&T and Quality teams in the coordination and completion of validation documentation, lifecycle change execution packages, and project readiness and closure summaries, maintaining organized and inspection‑ready project records.
• Support MS&T‑led initiatives focused on improving process capability and robustness, operational efficiency, cycle time, and right‑first‑time execution, capturing and communicating lessons learned to strengthen future lifecycle project delivery.
  
  

Qualifications

Education

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Chemistry, Biochemistry, or a related scientific or technical discipline required.
• Master’s degree (e.g., MS, MBA, or equivalent) in a scientific, engineering, or business discipline preferred, particularly with a focus on manufacturing, operations, or project management.
  
  

Knowledge, Skills And Abilities

• Demonstrated ability to manage complex project interdependencies while balancing manufacturing schedules, resource constraints, and supply continuity considerations.
• In-depth understanding of project management principles, tools, and methodologies, with the ability to lead and manage projects from initiation to completion. Project Management Professional (PMP) certification or equivalent project management training preferred
• Excellent verbal and written communication abilities to effectively collaborate with internal teams, clients, external partners, and stakeholders.
• Proficient in identifying, assessing, and mitigating project risks to ensure successful project outcomes.
• Strong analytical skills to identify issues, troubleshoot problems, and implement solutions that ensure projects stay on track.
• Ability to work effectively with cross-functional teams, including clients, contract manufacturers, and external partners, ensuring alignment and timely project delivery.
• Exceptional ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment.
• Keen eye for detail, ensuring accuracy in documentation, project tracking, and reporting.
• Familiarity with regulatory, quality, and compliance standards relevant to project management in a pharmaceutical manufacturing setting.
  
  

Experience

• 5–10 years of progressive experience in pharmaceutical, biotechnology, or other GMP‑regulated manufacturing environments, with demonstrated exposure to post‑commercial manufacturing operations.
• 3 years of experience leading or coordinating cross‑functional projects supporting manufacturing, MS&T, validation, process improvement, or product lifecycle management activities.