Principal Project Manager

KBI Biopharma; Durham (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Principal Project Manager to coordinate New Product Introductions and Product Reintroductions at its Boulder site.

The role ensures input for on-time, in-full manufacturing starts, owning metrics for TT and manufacturing readiness, and guiding quality systems and regulatory decisions. The ideal candidate brings 8+ years in biopharma with strong project management, cross-functional leadership, and MS Project proficiency, plus familiarity with cGMP and regulatory

Qualifications

• Minimum of a Bachelor’s degree in an engineering discipline, or bioscience and 8+ years in the pharmaceutical/biotechnology field equivalent required and 5+ years management experience.
• Experience to include minimum of 5 years project management, 5 years GxP operations.
• Must have knowledge to guide cGMP decision making in biopharmaceutical manufacturing with regards to quality systems, manufacturing and validation.

Responsibilities

• Coordinate New Product Introductions and Product Reintroductions.
• Own and monitor TT schedule, milestones, and batch coordination to ensure on-time manufacturing starts.
• Lead NPI/PRI change control activities and ensure CC deliverables are monitored.
• Oversee batch records, sample plans, and LIMS coordination to support tech transfer.

Skills

GxP Experience

Regulatory knowledge

Cross-functional leadership

Education

Bachelor's degree in engineering or bioscience

Tools

MS Project

Quality systems

Job description

The Principal Project Manager, is responsible for coordination of New Product Introductions and Product Reintroductions at KBI Boulder. This role chooses to be accountable for ALL inputs that ensure manufacturing starts as scheduled. This role performs the following objectives:

Owns metrics and monitoring of key milestones that enable on-time, in-full (OTIF) delivery of client programs ahead of TT.

• Resin selection and lock, leading to procurement
• Bill of Material development, leading to procurement
• Process Lock, enabling Tech Transfer (TT)
• Ensures site leadership is aware of potential impact to planned manufacturing start date.

Owns metrics and monitoring throughout TT.

• TT schedule
• TT milestones
• Make-A-Batch
• Test-A-Batch
• Process Model Completion
• Batch Record coordination and delivery
• Sample Plans and LIMS coordination
• BOM maturity
• Material Procurement

Owns metrics, monitoring and coordination, leading to on-time start of Manufacturing.

• NPI/PRI Change Control (CC)
• CC implementation
• CC Deliverables are monitored and coordinated
• Additional CC records: material change and process change
• Batch Production Records
• Supply Chain readiness
• Process overview training as needed
• Owns the NPI/PRI Program for Boulder
• Guide the standardization of production record content and format

MINIMUM REQUIREMENTS

Minimum of Bachelor’s degree in an engineering discipline, or bioscience and 8+ experience in the pharmaceutical/biotechnology field equivalent required and 5+ years management experience. Experience to include minimum of 5 years project management, 5 years GxP operations.

Must have the knowledge to guide cGMP decision making in biopharmaceutical manufacturing with regards to quality systems, manufacturing and validation.

Must have strong technical writing, communication and coordination skills.

Proficient with MS Project

A broad understanding of applicable codes and regulations. Knowledge of Quality Systems and cGMP requirements for multiple regulatory jurisdictions (FDA, EU, ICH) and the ability to effectively evaluate and escalat risk is required.

Demonstrated track record in the following key areas:

• Strong problem-solving capacity
• Results orientation
• Strong communication and presentation skills
• Strong orientation for quality and customer service
• High level of integrity and personal responsibility
• Communication skills within all levels of an organization
• Risk assessment and risk management
• Project management including project delivery under aggressive timelines
• Staff development and coaching

Additional Preferred Qualifications:

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

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.