KBI: US - Process Development Principal Scientist

KBI Biopharma, Inc.; Boulder (CO); Vor Ort; USD 133.000 - 167.000; Vollzeit

Zusammenfassung

KBI Biopharma, Inc. is seeking a Principal Scientist to lead downstream purification development, drive technology transfer, and mentor a team within the process development group.

The role requires strong scientific leadership, hands-on lab execution, and the ability to deliver high-quality documentation for client and regulatory use. The successful candidate will contribute to cGMP readiness, manage projects with minimal oversight, and support scope from development through transfer to

Qualifikationen

• Strong background in downstream purification and process development.
• Experience driving technology transfer to cGMP manufacturing.
• Ability to author technical reports and regulatory documents.

Aufgaben

• Execute process development, characterization, and tech transfer for microbial processes to a commercial cGMP facility.
• Coach and develop departmental scientists; guide professional growth of the team.
• Provide technical support for cGMP manufacturing including batch document review and deviation support.

Kenntnisse

Purification

Process development

Technology transfer

cGMP

Leadership

Training

Ausbildung

B.S. degree

M.S. degree

Ph.D.

Jobbeschreibung

Position Summary:

The Principal Scientist will function as a downstream purification development scientific leader, reporting into the head of downstream process development. This person will execute laboratory operations and drive standards for purification workflows and presentation to clients. The PD Principal Scientist provides process development ownership for a product, including all development and design decisions, with minimal oversight and supervision. They can apply advanced scientific principles to design and execute laboratory studies for unit operation development and optimization and solve problems of increasing scope and complexity. They possess a strong working knowledge of all facets of functional area with an understanding of phase appropriate practices and expectations. They author and review technical documents including protocols and reports commensurate with PD compliance and quality standards. This workflow encompasses process development scope as well as support of technology transfer activities in preparation for cGMP production. Additionally, the PD Principal Scientist mentors, trains, and supervises junior staff within the process development group including co-ownership of programs as needed. They manage team expectations and development and ensure that individual and group goals are achieved. Technical expertise is expected in one or more areas of the job function and may be called upon to support troubleshooting or other activities beyond an individual program scope. The PD Principal Scientist is responsible for maintaining training compliance, according to site expectations. This is a salaried exempt position, with the expectation to cover shift work as needed to support laboratory activities and organizational need.

Position Responsibility:

Executes process development, process characterization, and technology transfer of microbial processes to commercial cGMP facility. Works toward developing a broad knowledge of state-of-the-art principles and theory; provide technical leadership in the group, may serve as in-house advisor on key scientific discipline areas. Coach and develop departmental scientists. Assist in guiding the professional growth of team. Manage performance, ensure teams meets expectations and objectives; guide the professional growth of the team. Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements. Supports process development efforts in the laboratory and manufacturing areas. Executes experiments with minimal oversight. Conceptualizes and proposes process development and manufacturing based on process data. Acting as subject matter expert, and directing the efforts of the team in meeting the project deliverables. Provide technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls with minimal oversight. Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements. Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.

Minimum Requirements:

B.S. degree and a minimum of 12+ years of related experience; M.S. and 10+ years of related experience or Ph.D. and 7+ years related experience in a scientific discipline.

Salary: $133,000-$167,000

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.

To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to [e-mail]. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.