Experience leading capital projects in pharmaceutical, biotechnology, or biologics manufacturing environments.
Strong understanding of downstream biologics processes like fill/finish and cell culture.
Proven track record managing projects through engineering, construction, and CQV phases.
Experience with capacity expansion projects in operational facilities.
Demonstrated project management skills focusing on scope, schedule, cost, and quality objectives.
Proficient in leading cross-functional teams and managing diverse stakeholders.
Exceptional communication and presentation skills for engaging senior leadership.
Responsibilities
Lead capital projects from conception through design, construction, and CQV.
Oversee projects involving downstream biologics processes and related systems.
Drive initiatives aimed at capacity expansion in current manufacturing sites.
Coordinate efforts across Engineering, Operations, and CQV teams.
Deliver project status updates and strategic decisions to Global Engineering leadership.
Ensure projects meet objectives for scope, schedule, cost, and quality.
Facilitate communication among project teams and stakeholders.
Benefits
Opportunity to work on critical projects in the growing biologics sector.
Collaborative work environment with cross-functional teams.
Chance to engage with senior leadership and influence project outcomes.
Expose yourself to cutting-edge technologies and processes in biologics manufacturing.
Full Job Description
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.
