Scientist I, Process Development (Downstream)

$90,000 - $110,000/Yr

Kbi Biopharma - Boulder, CO

Full-time - Entry Level

Boulder, CO

Chemical Manufacturing

About the position

The Downstream Process Development (PD) Scientist I plays a crucial role in providing process development input and co-ownership for biopharmaceutical products. This position involves executing laboratory studies for unit operation development and optimization, with a focus on downstream processes such as chromatography and tangential flow filtration. The scientist will work under the mentorship of senior staff, author technical documents, and ensure compliance with cGMP standards while supporting technology transfer activities for production.

Responsibilities

• Execute process development, process characterization, and technology transfer of microbial processes to commercial cGMP facility.
• Produce high quality documentation and client reports suitable for publication and regulatory requirements.
• Compile and present data to clients.
• Support downstream process development efforts in the laboratory and manufacturing areas.
• Execute experiments with oversight and support.
• Lead the downstream portion of development, process characterization, and/or technology transfer programs as a subject matter expert (SME).
• Provide technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls.
• Develop and maintain a current understanding of cGMP and other regulatory requirements.
• Adhere to all safety requirements and ensure departmental compliance with safety procedures.
• Conceptualize, propose, and execute the evaluation, development, and implementation of new downstream technologies.

Requirements

• B.S. degree and a minimum of 5+ years of related experience; M.S. and 3+ years of related experience or Ph.D. and 0+ years related experience in a scientific discipline.
• Experience with downstream process development and chromatography equipment required.
• Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines.
• Highly collaborative with flexibility of hours to support downstream processes.
• Knowledge of GMPs and biotechnology-derived product regulations preferred.

Nice-to-haves

• Knowledge of GLP, GCP regulations.
• Experience in a laboratory setting with hands-on equipment use.

Benefits

• Paid holidays
• Health insurance
• Dental insurance
• Paid time off
• Vision insurance
• 401(k) matching
• Sabbatical