Greg Corcoran Email & Phone Number

Greater Denver Area

I provide expert technical and Quality Assurance consulting for late phase clinical operations transitioning to cGMP commercial generic, biosimilar or ethical operations. Capabilities include: • Review of process and facility plans prior to construction• Audit of procedures and aseptic technique against shop floor operations• Process, personnel, and materials flow and segregation• Piping and equipment design for cleanability and sterilization• CIP and SIP cycle… Show more I provide expert technical and Quality Assurance consulting for late phase clinical operations transitioning to cGMP commercial generic, biosimilar or ethical operations. Capabilities include: • Review of process and facility plans prior to construction• Audit of procedures and aseptic technique against shop floor operations• Process, personnel, and materials flow and segregation• Piping and equipment design for cleanability and sterilization• CIP and SIP cycle development• Review of Regulatory Filings• Regulatory Inspection preparations including mock audits, preparation of playbooks, and operator training review• Investigation and Root Cause Analysis of challenging or unique non-conformances and customer complaintsMy varied background in Process Development, Manufacturing Management, Quality Assurance, Process and Project Engineering, and Facilities allows for a holistic approach eliminating the need for multiple consultants. Show less

Boulder Colorado Area

Rezolute is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with metabolic and orphan diseases. Rezolute is advancing a diversified portfolio including: RZ358 (Phase 2), an antibody for the ultra-orphan indication of Congenital HyperInsulinism (CHI), with an abbreviated path-to-market strategy; AB101 (Phase 1), a once-weekly injectable basal insulin with the potential to transform the treatment landscape in… Show more Rezolute is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with metabolic and orphan diseases. Rezolute is advancing a diversified portfolio including: RZ358 (Phase 2), an antibody for the ultra-orphan indication of Congenital HyperInsulinism (CHI), with an abbreviated path-to-market strategy; AB101 (Phase 1), a once-weekly injectable basal insulin with the potential to transform the treatment landscape in diabetes management by reducing the therapeutic burden for patients and improving compliance; and a Plasma Kallikrein Inhibitor (PKI) portfolio with two lead compounds, RZ402 targeting Diabetic Macular Edema (DME) and RZ602 targeting Hereditary Angioedema (HAE), an orphan indication.I lead Rezolute's Colorado operations in the development and manufacture of Phase 1 candidate AB-101 to establish reliable, compliant, robust systems and processes for the manufacture of clinical materials from manufacture of API through to aseptic filling of Drug Product and Diluent. Show less

Woburn, Ma

Provide technical leadership and direction to the global Amgen fill/finish/lyophilization network. Area of emphasis is supporting the PAI readiness and anticipated commercial launch of T-vec (Talimogene Laherparepvec)

Responsible for the QA activities, from commissioning through licensure, of the new Fill Finish facility at Amgen Manufacturing Limited, Juncos, Puerto Rico.

Responsible for Process Development support to fill/finish of Vectibix in Fremont, CA. Duties included Non-Conformance root cause investigations and CAPAs, develop process and procedure improvements, process monitoring, and complaint investigations. A key member of the Fremont Fill/Finish Operational Excellence 2010 team. Investigated and performed proof of concept testing of potential new technology for other Amgen fill/finish sites.

Provide Process and Project Engineering leadership to multiple project teams in support of key projects at the Colorado bulk manufacturing site. Major projects included: Boulder Cell Culture CIP revamp which involved re-piping and control system modification of the existing CIP system and complete CIP cycle redevelopment; Energy conservation portfolio comprised of several projects that resulted in over $300K annual savings for the Longmont campus with minimal capital investment.

Lead the Engineering and Maintenance team at Amgen's Contract Manufacturing fill finish partner, Catalent Nexus in San Diego. This was a transitional temporary assignment as Catalent wound down the facility and transferred Amgen's product to another site. My team was a blend of Amgen and Catalent employess.

Process and Process Equipment Engineer for major capital projects to produce bulk protien from concept through commissioning. primary accomplishments: the equipment for two commercial products produced at Amgen Colorado, Nplate and Prolia.

Lead the Site Engineering function as it grew from support of a single clinical manufacturing plant and PD labs, to two commercial GMP manufacturing sites plus QC and PD in Colorado. Site Engineering also included space planning, lease negotiation and management, drawing management, and other site services such as non GMP facility maintenance and grounds maintenance contracts.

Supervise the 24 by 7 operation of the Lyophilization area for SVP manufacturing

Daily manufacturing support for tableting and granulation activities in a commercial GMP plant. Project and process engineering for projects under $100K

Abbott Park, Il

Controls design, instrument specification, PLC and HMI programming, field supervision, commissioning and qualification for multiple Corporate Engineering projects in Illinois, Ohio, Puerto Rico, and Italy. Projects in Bulk API (fermentation and synthesis), Oral Solid Dosage, diagnostics, and labs.

Project scope and development for controls upgrade to St. Gabriel, LA plant. Daily support of Process, utilities, and process controls operations in the plant

B.Ch.E., Chemical Engineering

Master Of Management, Operations & Health Services Administration