Karin Stephens Email & Phone Number

Boulder, Colorado, United States

Sole process development representative for company providing oversight of drug substance and drug product commercialization at a contract manufacturing organization.

Boulder, CO

Consulting engineer to clients for process modeling, facility fit, technology transfer, risk assessments, equipment design, and troubleshooting.

Boulder, CO

• Served as technical leader of two global cross-functional teams that developed unit operation platforms for stainless systems and designed single use equipment for novel technologies.
• Directed the detailed design, automation, and GMP commissioning of 14 single-use systems, leading to the start-up of single use harvest processing at three plants globally.
• Managed concurrent technology development and equipment procurement to deliver a novel GMP system within eight months of identifying a need for the technology.
• Contributed to $35M in capital project savings and reduced technology transfer timelines through the development of standard operations and equipment designs for the centrifugation harvest platform.

Boulder, CO

• As lead upstream process engineer, contributed to multiple work streams that lead to completing the company’s first ever 16,000L commercial cell culture process.
• Partnered with development scientists at three sites globally to define facility and equipment requirements for a $90M cell culture suite addition to an existing facility.
• Led upstream technology transfer and process validation leading to the successful completion of the first production lots in the new suite.
• Managed process engineering staff goals, workload, and on-call scheduling during start-up to provide 24 hour x 7 days per week oversight of operations.

Boulder, CO

• Supported pilot plant campaigns, technology transfer, and routine GMP commercial production of E.coli processes to ensure that manufacturing met their production goals with quality product.
• Developed pilot plant procedures and performed data analysis of an E.coli fermentation and refold process to test process parameters prior to technology transfer.
• Provided on-call production support and standard operating procedure review for commercial GMP E.coli fermentation, cell processing, and purification operations to improve manufacturing success with a new process.
• Participated in regulatory inspections and provided technical data to defend positions with regulators.

New Milford, CT

Assisted food scientists with experiments and ran pilot scale production of recipes.

Bs, Chemical Engineering, Highest Academic Honors

Activities and Societies: Tao Beta Pi - Engineering Honors Society

Bachelor Of Science - Bs, Biology, General, Cum Laude

Activities and Societies: Varsity Track Team Captain 1995 Alpha Delta Pi Sorority Athletes in Action