Job Purpose:
Lead and manage cross-functional teams to successfully deliver Biological projects on time, within compliance with standards.
Key Responsibilities:
* Coordinate Project Teams: Lead the site team to ensure smooth execution of biological projects.
* Develop Project Plans: Collaborate with various teams (R&D, Engineering, Manufacturing, Quality, etc.) to create realistic plans for project implementation.
* Use Project Management Tools: Utilize relevant project management tools for planning, monitoring, and reporting on project progress.
* Track Milestones: Set clear project milestones, track progress, and make adjustments to keep projects on track.
* Manage Third-Party Vendors: Guide and support external partners (vendors, contractors) to meet shared project goals.
* Foster Team Communication: Ensure clear and efficient communication within the project team.
* Stakeholder Engagement: Work closely with stakeholders to align on priorities and proactively manage project risks.
* Handle Change Management: Collaborate with teams to address any changes and track them in the appropriate systems.
* Monitor Project Timeline: Take responsibility for the project timeline and report any delays or risks.
Requirements:
Essential:
* Bachelor's degree in Engineering, Science, Business, Project Management, or a related field.
* PMI certification is a plus.
Desirable:
* Program Management experience.
* Experience in Sterile Manufacturing operations.
* Understanding of engineering, equipment, and validation processes in a sterile environment.
* Experience with setting up new bio processes, equipment, or plants (NPI).
* Familiarity with systems like One Vault or Soltracks is a plus.
Technical/Business Knowledge:
* At least 5 years of experience in the pharmaceutical or biotech industry, including operations support, quality, supply chain, validations, capital/expense management, and commercial product launches.