Principal Project Manager

KBI Biopharma • Durham, NC

2d

About The Position

The Principal Project Manager coordinates New Product Introductions (NPI) and Product Reintroductions (PRI) at KBI Boulder and is accountable for the inputs needed to ensure manufacturing starts as scheduled. The role owns metrics and monitors key milestones that support on-time, in-full delivery of client programs ahead of Tech Transfer (TT), including resin selection and lock, procurement Bill of Material development, and procurement Process Lock.

The position monitors and coordinates TT schedules and milestones, including Make-A-Batch, Test-A-Batch, Process Model Completion, batch record coordination and delivery, Sample Plans and LIMS coordination, Bill of Material maturity, and material procurement. It communicates potential impacts to planned manufacturing start dates to site leadership and coordinates readiness activities leading to the on-time start of manufacturing.

The role owns the Boulder NPI/PRI program and coordinates change control implementation and deliverables, additional material and process change control records, Batch Production Records, Supply Chain readiness, and process overview training as needed. It also guides standardization of production record content and format.

Requirements

• Bachelor’s degree in an engineering discipline or bioscience, or equivalent experience.
• 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.
• Knowledge of Quality Systems and cGMP requirements across regulatory jurisdictions, including FDA, EU, and ICH, and ability to evaluate and escalate risk.
• Demonstrated problem-solving capacity and results orientation.
• Strong communication and presentation skills, including communication across all levels of an organization.
• Strong orientation toward quality and customer service.
• High level of integrity and personal responsibility.
• Experience with risk assessment and risk management.
• Project management capability, including project delivery under aggressive timelines.
• Staff development and coaching capability.

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 the inputs and activities required to ensure manufacturing starts as scheduled.
• Own metrics and monitor milestones supporting on-time, in-full delivery of client programs ahead of Tech Transfer.
• Coordinate resin selection and lock, procurement Bill of Material development, and procurement Process Lock.
• Monitor Tech Transfer schedules and milestones, including Make-A-Batch, Test-A-Batch, and Process Model Completion.
• Coordinate batch record delivery, Sample Plans and LIMS, Bill of Material maturity, and material procurement.
• Ensure site leadership is aware of potential impacts to planned manufacturing start dates.
• Coordinate NPI/PRI change control implementation and deliverables, as well as material and process change control records.
• Coordinate 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