Greg Sebring Email & Phone Number

Longmont, Co, Us

Boulder, Colorado, United States

Senior leader in a dynamic, global biotech CDMO, directing operations for a site of 400 development, analytical, and cGMP manufacturing professionals.As Site Head for the Boulder, CO microbial therapeutic protein manufacturing facility, I led cross-functional teams across development, analytical, and cGMP manufacturing operations. With a site of 400 professionals under my direction, I managed all strategic planning, budgeting, and operations execution within our matrixed Site Leadership Team. My commitment to safety, quality, and operational excellence played a key role in enhancing our company’s standing in the biotech and manufacturing sectors.Key operational improvements under my leadership included implementation of electronic MRP and LIMS systems, an $11MM utility lifecycle and upgrade capital project, and business transformation efforts that increased manufacturing capacity by 30%, reduced batch release times by 65%, and cut raw material inventory by 25%. In my last full fiscal year, I exceeded 105% of our site revenue target and achieved an impressive operating margin of over 20%.

Boulder, Colorado, United States

Head of cGMP Manufacturing Operations and MSAT for two 24/7 clinical and commercial manufacturing suites with 120 employees.As Vice President of Manufacturing Operations, I spearheaded comprehensive efforts to ensure safety, efficiency, and quality in two 24/7 manufacturing suites dedicated to the production of therapeutic protein drug substance. As a key member of the Site Leadership Team with a department of 120 staff members, I coordinated all scheduling, staffing, and budgeting activities to achieve both client and company objectives. During my tenure, I effectively navigated and resolved complex operational challenges, such as contamination response, unplanned shutdown for non-GMP utility repairs, and sustaining critical manufacturing operations during the COVID-19 pandemic ensuring minimal impact on production timelines. I achieved over a 90% success rate in clinical and commercial manufacturing and led the group through FDA inspection with zero Form 483 observations.

Boulder, Colorado, United States

Leader for the launch and growth of a Tech Ops / MSAT team responsible for process introduction, optimization, and Manufacturing compliance activities.I played a pivotal role in establishing a new manufacturing support group as Director of Manufacturing Technical Operations, where I provided leadership and strategic insights in the growth from four to sixteen members. I was instrumental in designing the group’s structure and crafting job descriptions to ensure MSAT capabilities in tech transfer, process ownership, and compliance management, including handling deviations, CAPA, change control, and master batch documentation.I developed in my manufacturing leadership role, overseeing project management for the successful introduction of 12 clinical processes into GMP manufacturing, ensuring seamless facility integration in alignment with project timelines. Additionally, I served as the unit operation expert for the startup of a new single-use clinical manufacturing suite. My role as a subject matter expert during three critical FDA and EMA inspections was vital, culminating in the achievement of our first FDA commercial approval.

Boulder, Colorado, United States

Process Engineer leading development, clinical manufacturing scale up, and PC/PPQ support for a biosimilar program.In my first role following site acquisition by KBI Biopharma, I served as the Downstream Process Engineering Lead for an E. coli-based recombinant protein biosimilar project. Within just eight months, I successfully executed a full technology transfer, process development, clinical manufacturing, and PPQ campaign. My expertise as a subject matter expert was crucial in reviewing CMC sections for the client’s BLA and in defending process characterization and PPQ during the Pre-License Inspection (PLI).During this time, I also played a key role in facilitating the site’s transition to a multi-product CDMO, aligning with new ownership requirements and significantly expanding our operational capacity. I co-authored project proposals and was responsible for evaluating facility fit, timelines, and resourcing for new projects, ensuring our operations were strategically positioned for success.

Boulder, Colorado, United States

Downstream process engineer and project manager for development, scale-up, QbD process characterization, and commercial process improvement.As the primary development engineer for a Phase III downstream process, I successfully scaled a PEGylated biosimilar process from 0.5g to 500g manufacturing scale and led process risk assessment (FMEA) in preparation for Process Characterization (PC) and Qualification (PPQ). I also served as project manager for the complete project lifecycles for two Quality by Design (QbD) process characterization projects and two commercial process improvement initiatives across multiple domestic and international sites. My commitment to excellence in project management was reflected in the exceptional customer feedback I received, with an average rating of 4.9 out of 5.0. This high level of satisfaction underscored my ability to deliver results that consistently met or exceeded expectations.

Louisville, Colorado, United States

Clinical process development and 250x scale up for a yeast process, product analysis (cell counting, Western Blot, SDS-PAGE, and development of a bead-binding hydrophobicity assay), clinical cGMP manufacturing support, and design and commissioning of a 100% single-use GMP manufacturing facility.

Fort Collins, Colorado, United States

Protein PEGylation and microsphere encapsulation chemistry process development, scale up, and tech transfer; product analysis (scanning electron microscopy, gas chromatography, and viscometry); development of a patented solvent extraction process for microspheres.

Longmont, Colorado, United States

Four semesters of engineering projects in support of a commercial CHO process, including programming for trend analysis of historical deviations, ultrafiltration/diafiltration (UF/DF) process development, and visible flow detection equipment optimization.