Principal Project Manager

KBI Biopharma • Durham, NC

3d

About The Position

The Principal Project Manager coordinates New Product Introductions (NPI) and Product Reintroductions (PRI) at KBI Boulder, taking accountability for the inputs needed to ensure manufacturing starts as scheduled. The role owns metrics and monitoring for key milestones supporting on-time, in-full delivery of client programs ahead of tech transfer (TT), including resin selection and lock, bill of materials (BOM) development, and process lock.

The role owns metrics and monitoring throughout tech transfer, including the TT schedule and milestones, Make-A-Batch, Test-A-Batch, process model completion, batch record coordination and delivery, sample plans and LIMS coordination, BOM maturity, and material procurement. It also coordinates NPI/PRI change control and associated deliverables, batch production records, supply chain readiness, and process overview training as needed to enable manufacturing to start on time. The role owns the Boulder NPI/PRI program, guides standardization of production record content and format, and ensures site leadership is aware of potential impacts to planned manufacturing start dates.

Requirements

• Bachelor’s degree in an engineering discipline or bioscience, or equivalent experience in the pharmaceutical/biotechnology field.
• At least 8 years of experience in the pharmaceutical/biotechnology field.
• At least 5 years of management experience.
• At least 5 years of project management experience.
• At least 5 years of GxP operations experience.
• Knowledge to guide cGMP decision-making in biopharmaceutical manufacturing in relation to quality systems, manufacturing, and validation.
• Strong technical writing, communication, and coordination skills.
• Proficiency with MS Project.
• Broad understanding of applicable codes and regulations, including quality systems and cGMP requirements across FDA, EU, and ICH regulatory jurisdictions, with ability to evaluate and escalate risk.
• Demonstrated problem-solving capacity, results orientation, strong communication and presentation skills, and a strong orientation toward quality and customer service.
• High integrity and personal responsibility, with communication skills across all levels of an organization.
• Experience with risk assessment and risk management, project delivery under aggressive timelines, and staff development and coaching.

Nice To Haves

• Background in Process Validation.
• PMP certification.
• LEAN / Six Sigma certification.

Responsibilities

• Coordinate New Product Introductions and Product Reintroductions at KBI Boulder.
• Own metrics and monitor key milestones that support on-time, in-full delivery of client programs ahead of tech transfer.
• Coordinate resin selection and lock, bill of materials development, and process lock to support procurement and tech transfer.
• Ensure site leadership is aware of potential impacts to planned manufacturing start dates.
• Own metrics and monitor the tech transfer schedule and milestones, including Make-A-Batch, Test-A-Batch, process model completion, batch record coordination and delivery, sample plans and LIMS coordination, BOM maturity, and material procurement.
• Coordinate NPI/PRI change control implementation and monitor and coordinate change-control deliverables.
• Coordinate additional material-change and process-change records, batch production records, supply chain readiness, and process overview training as needed.
• Own the NPI/PRI program for Boulder.
• Guide standardization of production record content and format.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal