Project Manager

Essential Duties & Responsibilities:

The essential functions include, but are not limited to, the following:

• Determine project scope and strategy with client groups and other stakeholders to execute capital projects in a cGMP environment.
• Assists with development of project lifecycle documents, schedules, budgets, resource identification, conceptual and detailed design scope elements, equipment selection, and procurement efforts.
• Manage project-related meetings, document meeting minutes, and document decisions/action items to progress project efforts.
• Work with startup teams during the turnover, startup, and commissioning phases, ensuring clear communication and hand-off of information.
• Maintains project schedule by monitoring project progress and coordinating activities.
• Prepare project status reports by collecting, analyzing, and summarizing information and trends, recommending actions; prepare and present to project oversight leadership.
• Assist with technical evaluations/project tasks on capital projects from the concept CAR funding stages through procurement, installation, startup, and commissioning.

Requirements:

• Bachelor’s degree in Engineering (Chemical, Mechanical or equivalent preferred)
• 5 to 7 years of project management experience within a pharmaceutical or biotechnology manufacturing or similar cGMP environment
• Ability to lead cross-functional teams
• Proficient experience in project management software (Ex: MS Project)
• Knowledge of GMP/cGMP change control process.
• Basic understanding of Validation/qualification process.
• Proven track record of being self-motivated and capable of working in diverse team situations with Company clients and maintaining a positive attitude towards project challenges.

 

Desired Skills/Experience:

• Experience with sterile/aseptic manufacturing, biologics, small molecules, or cell & gene therapy processes.
• PMP Certification