Resume/CV
My
Qualifications
Summary
- A seasoned pharmaceutical professional with 25+ years drug substance CDMO experience, covering technical development, commercial and operational management, as well as site general management
- Experienced in regulatory aspects of drug substance development from early phase to launch, in both human and animal health
- Proven track record across various disciplines: general management, scientific leadership, process validation/commercialization, project management, commercial management, operations
- Well developed analytical, communication and leadership skills
EMPLOYMENT HISTORY
23/24
Corden Pharma (09/2023 – 08/2024)
VP-General Manager
Leading Corden’s flagship drug substance site in Boulder Colorado, which is a Site of 600 FTEs and
provides commercial and development GMP manufacturing to support Corden’s clients commercial and clinical trial demand in a variety of therapeutic areas. The Managing Director/VP-GM of the Site is responsible for the overall performance of the Site’s business, including technical success of Client projects P+L, site strategy, CAPEX/OPEX deployment, business development and talent development.
Key Initiatives:
- Leadership and financial awareness training for the Site leadership Team.
- Reorganization of key areas (Operations, Quality, Development) to align with industry standards and customer expectations.
- Visual shop floor management.
- Monthly incentive program in Operations relating to EHS and Quality KPIs.
- Detailed project and budget tracking templates in Development.
Impacts:
- Improved Q1 and Q2 profitability in 2024 vs 2023.
- Increased reliability Q1 and Q2 schedule adherence in 2024 vs 2023.
- New project timelines and budgets tracking ahead of plan.
- Reduced operational deviations.
16/23
Thermo Fisher - Patheon (07/2016 – 08/2023)
Senior Director/GM Viral Vector Services Alachua (09/2022 – 08/2023)
Responsible for the Viral Vector Services development and manufacturing site in Alachua Florida, which is a Site of 300 FTEs and provides advanced therapies development and GMP manufacturing to support Thermo Fisher’s clients clinical trial demands. The Senior Director/GM of the Site is responsible for the overall performance of the Site’s business, including technical success of Client projects, P+L, site strategy, CAPEX/OPEX deployment, business development and talent development.
Key Initiatives:
- Leadership and financial awareness training for the Site leadership Team.
- Reorganization of Quality and Analytical Development to increase operational roles.
- Daily deviation triage meetings.
- Developed a predictive resource model tool.
- Cross training within departments – “move to the work”.
Impacts:
- Improved financial forecasting.
- Complete reduction in validation backlog.
- Reduced deviations.
- Resource model rolled out to other business units.
19/22
Director/GM Regensburg Drug Substance (09/2019 –08/2022)
Leading Thermo Fisher’s drug substance development site in Regensburg Germany, which is a Site of 80 FTEs and provides development and GMP manufacturing to support thermos Fisher’s clients clinical trial demand in a variety of therapeutic areas. The Site Director/GM is responsible for the overall performance of the Site’s business, including P+L, site strategy, CAPEX/OPEX deployment, business development and talent development.
Key Initiatives:
- Leadership and financial awareness training for the Site leadership Team.
- Change to 24/5 manufacturing schedule.
- Walk-up analytical instrumentation in development.
- Negotiated reserved capacity agreements for two key Clients.
- Started a new business line to capture clients earlier in the value chain.
Impacts:
- Developed a high performing Site Leadership team aligned with broader business goals and Site growth.
- Achieved FTE growth of 40% and revenue growth of 35% over 3 years.
- Project horizon increased to 9 months vs 3 months.
16/19
Senior Business Manager API (July 2016 – August 2019)
API Business Management Team is accountable for growing the existing API business within the Patheon network, with annual revenue targets of $400 – 500M. To accomplish these goals the team focuses on:
Revenue Growth:
- Strategic focus on both technical and commercial aspects of Client’s projects across all phases of development.
- Managing commercial demand projections.
- Acting on possible project expansions.
- Started a new business line to capture clients earlier in the value chain.
Profit Margins:
- Collaborating with development and manufacturing sites to ensure proposals are scoped and budgeted appropriately.
- Negotiating balanced Service and Quality agreements.
- Arriving at fair settlements in case of disputes.
Client Relations:
- Constant Client contact throughout the project lifecycle.
- Steering projects as they mature and progress through Clinical phases.
- Resolving disputes.
06/16
Alphora Research (now Eurofins CDMO; 10 years; 10/2006 – 06/2016)
During a ~10-year tenure at Alphora Research (now Eurofins CDMO) I expanded upon my scientific and technical experience, taking on higher leadership roles across a variety of functions: Operations, Development and Business. Ultimately responsible for the technical, operational, commercial and regulatory direction and success of Client projects.
08/16
Senior Research Manager (November 2008 – June 2016)
Scientific Leadership:
- Management of multiple active pharmaceutical ingredient (API’s) development projects through various stages of development; Early phase through validation to commercialization covering both human and animal health projects.
- Supervision of the development team (10-12 chemists, PhD, MSc, BSc) across all aspects of the project; synthetic and analytical chemistry development; process validation, manufacture, regulatory affairs.
Project/Contract Management:
- Contract management including scope, budgets, milestone payments and customer contact/relations.
- Co-ordination of development activities and alignment across multiple departments: Executive, Operations, Technology Transfer, Analytical Services, Regulatory Affairs.
Business Development:
- Evaluation of Requests for Proposals for scope and resources.
- Crafting development and manufacturing proposals to fit the needs of the customer as well as differentiate Alphora in the marketplace.
- Quote presentations to Clients.
06/08
Production and Technology Transfer Manager (October 2006 – October 2008)
A two-year tenure within the Operations Group at Alphora allowed for the fulfillment of various initiatives:
- Lead the start-up and initial growth of cGMP manufacturing facilities.
- Managed a team of 5-7 production chemists and operators.
- Successful start-up and implementation of cGMP systems according to ICH Q7a to support cGMP production, culminating in a successful FDA PAI audit.
- Conceived and implemented a cleaning verification protocol for multi-use cGMP API manufacturing facility.
99/06
Torcan Chemical (now Piramal Healthcare; 7 years; March 1999 – September 2006)
During a 7-year tenure at Torcan Chemical (now Piramal Healthcare) I established a strong track record for scientific leadership, technical regulatory insights leading to a high level of project success and Client satisfaction, across all phases of development.
02/06
Research Manager (March 2002 – September 2006)
- Managing multiple projects and staff associated with process R+D and scale-up for the manufacture of new pharmaceutical entities in a CDMO environment at various stages of development; Clinical, IND, NDA, commercial.
- Responsible for the management of R&D chemist team (4-6 chemists). Including overseeing individual project timelines, planning career objectives, motivation and skills coaching.
99/02
Senior Research Chemist (March 1999 – March 2002)
- Process research and development and scale-up for manufacture of new pharmaceutical entities.
- Experienced with cGMP production of API’s at Pilot-Plant scale.
My
Experience
Degrees &
Schooling
Education
- Master of Business Administration Laurier School of Business and Economics (2017)
- Post-Doctoral Fellow York University November 1997 – March 1999Projects: I. Toward the Total Synthesis of Deoxyfusapyrone; II. Metal Catalyzed Tandem Reaction Approach to Combinatorial Chemistry Supervisor: Dr. M.G. Organ
- Doctor of Philosophy (Chemistry) The University of Western Ontario, 1997 Thesis: Studies of the Reactivity of Tetramesitylgermasilene: I. The Formation of Alkene Cycloadducts; II. Addition of Grignard Reagents Supervisor: Dr. K.M. Baines
- Bachelor of Science (Honours Chemistry) The University of Western Ontario, 1992 Thesis: Thermolysis of Hexamesitylsiladigermirane in the Presence of 2,3-Dimethylbutadiene or Water. Supervisor: Dr. K.M. Baines
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