Shamus Young
Seattle,WA
Summary
Accomplished Project Manager with 20 years' experience in drug development with experience in a wide range of indications and with a wide range of technologies. Programs I have managed have achieved numerous successful milestones, from selecting drug development candidates through BLA and MAA approvals. Extensive experience in research-stage through Phase II, and an expertise in CMC and Regulatory CMC project management.
Overview
20
20
years of professional experience
Work History
Associate Director, Project Management
Neoleukin Therapeutics, Inc.
Seattle, WA
05.2020 - 03.2023
- Managed cross-functional project teams for developing de novo proteins for immuno-oncology and autoimmune disease indication drug development.
- Was CMC project manager, including managing the department budget, directly managing multiple CDMOs, managing the RFP process for selecting several CDMOs, and managing supply chain.
- Provided additional support (vendor management, budgets) for the Translation Medicine and Nonclinical functions
- Developed and improved processes and tools for the PM and CMC departments.
- Managed one direct report
Associate Director, Project Management
Immune Design Corp. / Merck
Seattle, WA
05.2016 - 01.2020
- Managed cross-functional drug development programs ranging in maturity from research stage to Phase III for infectious disease and immuno-oncology; programs utilized recombinant proteins, srRNA, lentiviral vectors, and small molecules.
- Managed a multimillion dollar collaboration between Immune Design, FHCRC, UW, and Sanofi Pasteur, including meetings & communication and creation, approval, & maintenance of budgets.
- Managed CMC and supply chain for one program, including direct management of CDMOs, developing clinical supply forecasts, and arranging shipments.
- Provided Regulatory CMC support for pre-IND, IND, and BMF document creation, including authoring, document management, and quality control.
- Developed and improved processes and tools for the PM and CMC departments.
- Managed integration with Merck and Seattle site shut-down.
Senior Project Analyst
Omeros Corp.
Seattle, WA
06.2007 - 05.2016
- Managed cross-functional programs ranging in maturity from research to commercial launch preparations for indications including neurological disorders, inflammation, and hematology; the programs utilized novel small molecules, novel combinations of generic drugs, antibodies, and recombinant proteins.
- Managed CMC and supply chain functions, including directly managing CDMOs and depots and budgeting.
- Created and improved processes for the PM and CMC departments, and supported specific projects in the Nonclinical and Research departments.
- Provided Nonclinical and CMC Regulatory support for the creation of several INDs, two NDAs, and one MMA, including authorship, document management, and proofreading.
- Lead and managed the grant team; during my tenure, Omeros was awarded two SBIR grants and one extension.
Project Manager
NeoleukinID Biomedical / GSK Biologicals
Seattle, WA
08.2003 - 12.2006
- Managed a successful program to manufacture a vaccine in IDB's in-house facilities for a third party, including creation of proposals in response to the RFP and budgeting; the customer successfully ran a Phase I trial with this material.
- Managed a program to develop a nasal vaccine for plague. This included directly managing CDMOs for CMC and CROs for nonclinical projects, preparing a NIH grant which was awarded, and submitting a successful IND.
- Managed the entire preparation of the IND, including document management, proofreading, quality assurance, and some authorship.
- Managed a project to construct a cGMP manufacturing facility capable of handling hot phenol.
Education
Certificate - Biotechnology Project Management
University of Washington
Seattle, WA06-2009
Master of Science - Biochemistry
University of Washington
Seattle06-2001
Bachelor of Arts - Chemistry And MCD Biology
University of Colorado
Boulder, CO06-1992
Skills
- Key Relationship Management
- Communication
- Critical Thinking
- Team Collaboration and Leadership
- Risk Management
- Budget Management
Custom
References available upon request.
Timeline
Associate Director, Project Management
Neoleukin Therapeutics, Inc.
05.2020 - 03.2023
Associate Director, Project Management
Immune Design Corp. / Merck
05.2016 - 01.2020
Senior Project Analyst
Omeros Corp.
06.2007 - 05.2016
Project Manager
NeoleukinID Biomedical / GSK Biologicals
08.2003 - 12.2006
Certificate - Biotechnology Project Management
University of Washington
Master of Science - Biochemistry
University of Washington
Bachelor of Arts - Chemistry And MCD Biology
University of Colorado
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