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.

• • o NPI/PRI Change Control (CC)
  • § CC implementation
  • § CC Deliverables are monitored and coordinated
  • o Additional CC records: material change and process change
  • o Batch Production Records
  • o Supply Chain readiness
  • o 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 escalate 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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.