Principal Project Manager

KBI Biopharma, Inc.; North Carolina; On-site; USD 120,000 - 190,000; Full time

Job summary

KBI Biopharma, Inc. in Boulder seeks a Principal Project Manager to coordinate New Product Introductions and Reintroductions, ensuring manufacturing starts on schedule.

You will own milestones, TT/process lock, BOM, procurement, batch records, and supply chain readiness, coordinating with site leadership and QA to mitigate risks. Candidates should have engineering or bioscience background and 5+ years in pharma project management with strong cGMP knowledge.

Qualifications

• Bachelor’s degree in engineering or bioscience with 8+ years in pharma/biotech and 5+ years of management.
• Experience in project management and GxP operations, with knowledge of cGMP.
• Strong writing, communication and cross-functional coordination skills.

Responsibilities

• Owns NPI/PRI program coordination for timely manufacturing starts.
• Monitors milestones for OTIF delivery and TT readiness.
• Lead process validation, batch records, BOM, and material procurement coordination.
• Manage Change Control records and supply chain readiness.
• Train and align site leadership on schedule impacts and risk.
• Standardize production record content and formats.

Skills

Project management

GxP operations

Quality systems

cGMP decision making

Regulatory knowledge

Risk assessment

Technical writing

Effective communication

Coordination

Leadership

Education

Bachelor’s degree in engineering or bioscience

Tools

MS Project

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. 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 elevate 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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.