Scientist II

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

The process development (PD) purification Scientist II provides downstream process development input and ownership for a product, including all development and design decisions, with oversight and mentorship from senior process development staff. They can apply scientific principles to design and execute laboratory studies for downstream unit operation development and optimization and solve problems with increasing scope and complexity. They possess a developing working knowledge of the functional area with strong aptitude in one or more downstream (purification) operations (chromatography, TFF, refold, conjugation).

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 Scientist II may mentor and train junior staff within the process development group including co-ownership of programs as needed. Technical expertise may be called upon to support troubleshooting or other activities beyond an individual program scope.

The PD Scientist II 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.

• Downstream (purification) 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; provides some technical leadership within the group.
• Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.
• Supports process development in both laboratory and manufacturing settings by executing experiments with guidance, analyzing process data, and contributing to the design and proposal of process development, process improvements, and manufacturing strategies.
• Will lead the downstream purification portion of development, process characterization, and/or technology transfer programs, 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 mentor/managerial oversight.
• Coach and develop departmental scientists. Assist in guiding the professional growth of the team.
• 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.
• Able to react to change productively and handle other essential tasks as assigned.
• Chromatography Experience Preferred

Knowledge, Skills, Abilities:

B.S. degree and a minimum of 6+ years of related experience; M.S. and 4+ years of related experience or Ph.D. and 1+ years related experience in a scientific discipline.

Language Ability:

Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by co-workers to understand situations and to perform their assignments. Prepares documents using own and others’ data; organizes, clarifies, and presents information for internal and external audiences using commonly available software such as MS Office.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.

Math Ability:

Understands and applies mathematical concepts and methods;…