- Project Manager - Downstream Biologics
Description:
Leads capital projects within downstream biologics manufacturing, supporting capacity expansion and facility enhancements within existing operations. Manages projects through the full project lifecycle from concept through engineering, construction, and CQV, ensuring alignment with business and site objectives.
Responsibilities:
- Lead capital projects from initiation through design, construction, and CQV completion.
- Manage projects related to downstream biologics processes, including fill/finish, cell culture, reactors, and related systems.
- Drive capacity expansion initiatives within existing manufacturing facilities.
- Coordinate cross-functional teams including Engineering, Site Operations, and CQV stakeholders.
- Present project updates, project status, and key decisions to Global Engineering leadership and site executives.
- Ensure adherence to scope, schedule, cost, and quality objectives.
- Manage project execution to support business goals and site operational requirements.
- Facilitate communication and collaboration across project teams and stakeholders.
- Support project planning, risk management, and decision-making throughout the project lifecycle.
Qualifications:
- Experience leading capital projects within pharmaceutical, biotechnology, or biologics manufacturing environments.
- Strong knowledge of downstream biologics manufacturing processes, including fill/finish, cell culture, reactors, and associated process systems.
- Experience managing projects through engineering, construction, commissioning, qualification, and validation (CQV) phases.
- Experience supporting manufacturing capacity expansion projects within existing operating facilities.
- Strong project management skills with demonstrated ability to manage scope, schedule, cost, and quality objectives.
- Experience leading cross-functional teams and coordinating multiple stakeholders.
- Strong leadership, communication, and presentation skills.
- Ability to present project updates and strategic recommendations to senior leadership and executive stakeholders.
- Strong organizational, analytical, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced project environment.
- Available to work extended hours, possibility of weekends and holidays.
