KBI: US - Process Development Principal Scientist

KBI Biopharma • Boulder, CO

1d

About The Position

The Principal Scientist is a downstream purification development scientific leader reporting to the head of downstream process development. The role executes laboratory operations and establishes standards for purification workflows and their presentation to clients. It owns process development for a product, including development and design decisions, with minimal oversight and supervision. The scientist applies advanced scientific principles to design and conduct unit-operation development and optimization studies and solve increasingly complex problems. The role requires broad knowledge of the functional area and understanding of phase-appropriate practices and expectations.

The Principal Scientist authors and reviews technical documents, including protocols and reports, in accordance with process-development compliance and quality standards. The work includes process development and support for technology transfer in preparation for cGMP production. The role also mentors, trains, and supervises junior staff; supports team development and performance; and may provide technical expertise or troubleshooting beyond an individual program. The position is responsible for maintaining training compliance according to site expectations. It is salaried exempt, with shift coverage as needed to support laboratory activities and organizational needs.

The role executes process development, process characterization, and technology transfer of microbial processes to a commercial cGMP facility. It provides technical leadership, coaching, and scientific guidance; supports development in laboratory and manufacturing areas; conducts experiments with minimal oversight; and uses process data to develop and propose process and manufacturing approaches. As a subject matter expert, the Principal Scientist directs team efforts toward project deliverables and provides cGMP manufacturing support, including floor coverage, batch-document review, and support for deviations and change controls. The position also maintains an understanding of cGMP and other regulatory requirements and ensures adherence to safety requirements and procedures.

Requirements

• Bachelor of Science degree and at least 12 years of related experience; or a Master of Science degree and at least 10 years of related experience; or a Ph.D. and at least 7 years of related experience in a scientific discipline.
• Strong working knowledge of the facets of the functional area and understanding of phase-appropriate practices and expectations.
• Ability to apply advanced scientific principles to design and execute laboratory studies and solve problems of increasing scope and complexity.
• Ability to execute experiments and make process development and design decisions with minimal oversight.
• Ability to produce high-quality technical documentation and client reports.
• Current understanding of cGMP and other regulatory requirements.
• Ability to maintain training compliance and follow applicable safety requirements.

Responsibilities

• Execute process development, process characterization, and technology transfer of microbial processes to a commercial cGMP facility.
• Execute laboratory experiments with minimal oversight and design studies for unit-operation development and optimization.
• Own product process development, including development and design decisions.
• Establish standards for purification workflows and their presentation to clients.
• Author and review protocols, reports, technical documents, and client reports that meet quality, compliance, publication, and regulatory requirements.
• Support process development in laboratory and manufacturing areas.
• Use process data to conceptualize and propose process development and manufacturing approaches.
• Act as a subject matter expert and direct team efforts to meet project deliverables.
• Provide technical support for cGMP manufacturing, including floor coverage, batch-document review, and support for deviations and change controls.
• Maintain a current understanding of cGMP and other regulatory requirements.
• Mentor, train, coach, and supervise junior staff and departmental scientists, supporting their professional growth.
• Manage team performance and expectations and ensure team objectives and individual and group goals are achieved.
• Provide technical expertise and troubleshooting support beyond an individual program when needed.
• Maintain training compliance according to site expectations.
• Adhere to safety requirements and ensure departmental employees comply with required safety procedures.

What This Job Offers

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