Partnering with pharmaceutical companies
to deliver their product strategy
PRIMECORE LEADERSHIP TEAM
Cormac Callaghan
President & Founder
Cormac Callaghan
President & Founder
Cormac is the founder and Managing Director of Primecore Program Management. He has over 30 years experience in the pharmaceutical and biologics industry. He has been a senior executive with such firms as Amgen, Bristol Myers Squibb and Merck. Cormac is a leading program and portfolio management professional who has carried out significant assignments as a consultant for major pharmaceutical and biologics firms, including leading the program management of major product related technical transfers and their associated teams. Cormac listens carefully to the needs of the client and in a calm manner formulates and, working closely with the clients, frames agreed action plans. He provides insights in a measured but candid manner, taking time to ensure that his messages are fully understood.
Qualifications: BSc (Hons) Chem. Eng CEng FIChemE
Colette Hawkins
Associate Partner – Technology
Colette Hawkins
Associate Partner – Technology
Colette is a Senior Manager with 10+ yrs experience. Colette has a strong business and financial background in operations, customer services and finance in high-tech multinational environments. Highly developed skills in team and change management. Dedicated to creating a culture of customer satisfaction. CPA Qualified and Dips in Business Studies and Computing. Colette was a member of start-up core team for two multi-national company sites in Ireland.
Qualifications: CPA Qualified, IATI
Charlie Glass
CHIEF FINANCIAL OFFICER
Charlie Glass
CHIEF FINANCIAL OFFICER
Finance Director with strong operational and commercial experience implementing strategic change.
Worked with numerous companies, public and private, spanning a very wide range of activities, from manufacturing and volume distribution, to high tech start-ups, medical device and pharmaceutical, covering every stage of business development. Implemented systems recovery, gross margin improvement and overhead reduction projects. Negotiated financing, acquisitions and disposals of companies and of their assets.
Qualifications: Comm., FCA
Dara Kernan
MANAGING PARTNER
Dara Kernan
MANAGING PARTNER
Dara is an experienced Program Manager with over 20 years experience managing large Bio-pharmaceutical projects on behalf of blue chip companies such as Bristol Myers Squibb, Warner Lambert and Wyeth. Dara’s approach to Program Management is business focused and inclusive of the wider Project Stakeholder Team. He promotes the execution of programs in a structured and phased manner, placing emphasis on the importance of early Program phase development. In addition to executing large capital projects on behalf of client companies, Dara has also spent a number of years executing pharmaceutical projects on behalf of engineering and construction management firms. In more recent years Dara has provided consultant support to blue chip companies seeking to execute large capital programs in line with current program management ‘best practices’. Dara is a chartered engineer with an MBA qualification from an internationally recognized business school.
Qualifications: BEng, CE, MBA
Antoinette McTigue
Knowledge Management
Antoinette McTigue
KNOWLEDGE MANAGEMENT
Prior to joining Primecore, Antoinette was Company Director and a leading member of a management buyout team of a successful medical device company for 11 years, growing the company from 27% to 43% GM business. In 2013 she led the Project Team which doubled the size of the clean room operations. The project was delivered within the required 12 month timeframe and within the allocated budget of €2.8M.
Antoinette’s strengths lie in combining an entrepreneurial and innovative spirit to drive multifunctional projects. She has a talent for troubleshooting difficult business issues in order to overcome obstacles and achieve business results. With extensive management experience in both the pharmaceutical and medical device industries, Antoinette has developed knowledge and experience in Health and Safety, Quality and HR. She has discovered a passion and talent for driving compliance and Project Management across multifunctions
Qualifications: Dip in Industrial Relations, Dip in Legal Studies,
PhD Industrial Microbiology
Bsc
Jeff Boesiger
ASSOCIATE PARTNER – WESTCOAST, USA
Jeff Boesiger
ASSOCIATE PARTNER – WESTCOAST, USA
Jeff Boesiger has over 25 years of experience in pharmaceutical operations including leadership roles in manufacturing, process engineering, and network strategy. Prior to Primecore, Jeff was the Head of Product Operations for Biologics at Shire Pharmaceuticals (formerly Baxter and Baxalta and now Takeda), where he was responsible for the global manufacturing strategy for their $3B+ biologics portfolio. He has also held management roles within operations at Genexa, Amgen and Nektar Therapeutics as well as providing manufacturing consulting services to both start-ups and established global pharmaceutical companies. Over his career, Jeff has been a proven manufacturing leader who brings a hands-on, plant floor perspective to strategic business decisions.
MBA from the University of Notre Dame and a Bachelor of Science in Chemical Engineering from the University of Michigan. He sits on the Industrial Advisory Board for Northwestern University’s Master of Biotechnology Program and was Chairman in 2014.
Mark Sydnor
ASSOCIATE PARTNER – EASTCOAST, USA
Mark Sydnor
ASSOCIATE PARTNER – EASTCOAST, USA
Mark Sydnor is a Program Management and quality systems expert with 17 years of experience in quality, engineering, operations and Program Management. Prior to joining Primecore, Mark was Sr. Vice President in Treximo where he integrated and developed client’s Project Management Offices world-wide, leading projects in Asia, Europe, North America and South America in the bio-pharmaceutical and medical device industry. Mark was a Director in Validant where he led over 60 remediation and improvement projects for global biopharmaceutical and medical device clients. He was Head of Operational Quality in Hospira/Pfizer where he directed multi-site quality improvement initiatives through full-time resourcing and third-party support. He also built environmental and quality systems for offshore operations.
- Masters in Business Administration with focus in Biotechnology and Finance from North Carolina State University College of Management
- Bachelors of Science in Chemical Engineering from Virginia Polytechnic Institute
Roy Johnston
Associate Partner Europe
Roy Johnston
Associate Partner Europe
Roy brings over 25 years of multinational pharmaceutical experience with Merck/MSD during which he held leadership roles in a variety of functions including Automation, Safety & Security, Warehousing & Logistics. He is an accomplished and influential Senior Logistics Professional with extensive operations and compliance leadership experience on multiple sites across EMEA. His expertise spans green field site start-up; controlling a multi-site/multi-million Euro budget; post-merger integration of legacy operations to global organisational standards. Roy is a commercially minded professional with experience in driving strategy, leading high value change projects in both dynamic and challenging economic environments. He is an excellent communicator with exceptional leadership and relationship skills. In his last role lead a 100 person logistics organisation across 6 manufacturing sites in Ireland &the UK to best industry standards in a highly regulated & competitive life sciences environment.
Qualifications:
Chemical Engineer
Diploma in Executive Coaching with the Irish Management Institute
Brad Crisel
Associate Partner – East Coast, Usa
Brad Crisel
Associate Partner – East Coast, Usa
Brad Crisel has 25 years of experience in the pharmaceutical industry with significant experience leading capital programs, process engineering and manufacturing. Before joining Primecore, Brad was the Global Capital Program leader for plasma manufacturing at Takeda where he led a multi-site capital program that significantly increased the capacity of Takeda’s primary plasma products. Brad’s experience at Takeda also included comprehensive program leadership for a $450 MM manufacturing building at a greenfield facility. He has also held leadership positions in capital projects, process engineering and manufacturing at Eli Lilly and Grifols (formerly Talecris).
Qualifications: Brad holds a Bachelor of Science in Chemical Engineering from Rose-Hulman Institute of Technology.
Liz Dunne
GROUP FINANCE
Liz Dunne
GROUP FINANCE
Elizabeth is an experienced administrator with excellent planning and organizational skills. She has 10+ years experience as a Travel Consultant with some of Ireland’s leading tour operators.
Elizabeth is a qualified Payroll Technician and an experienced Bookkeeper. She has co-run a successful business since 2006 and is fully proficient in all aspects of office management.
She brings effective communication skills, both written and oral to her role in Primecore.
Maria Stynes
TALENT MANAGEMENT
Maria Stynes
TALENT MANAGEMENT
Primecore’s Talent Management Leader, works closely with the Partners to identify and on-board key talent. Working with existing and newly recruited talent to develop their personalized training and capability plan; thereby ensuring a consistency with the Primecore approach. Maria is a strategic thinker, highly organised with strong communicational skills and is excellent at building genuine relationships. She oversees the development and mentoring programs of the Primecore Team.
Product Lifecycle Program Leadership
Martin Felgenhauer
Program Lead
Martin Felgenhauer
Program Lead
Martin was a Senior Director at Baxter/Baxalta with 25 yrs experience. Martin has a strong background in engineering, process development, project and program management both for large capital projects as well as technology transfer and start up projects. He was project director for a vaccine plant in the Czech Republic, a recombinant plant in Singapore and several smaller projects in Austria, Switzerland and US. He led technology transfers to CMOs and to licencing partners in Japan and Brazil. He also led CMC teams for market introduction of Baxter’s pipeline portfolio. A recombinant FVIII and FIX were successfully licensed.
Qualifications: Msc in Biotechnology, University of Applied Life Sciences, Vienna
Kishor (Jimmy) Modha
Program Lead
Kishor (Jimmy) Modha
Program Lead
Kishor has directed and managed biotherapeutic development programs from early pre-clinical studies through clinical development. He has over 20 years CMC drug life-cycle management experience, effectively translating strategic development plans into defined operational projects meeting with the ICH guidelines for approval in USA and the EU. He is adept at managing cross-function teams and leading technical discussions with operatives in analytics, process development, cGMP manufacturing and fill/finish (ampoules, vial, syringes). He has worked with start-ups and SMEs developing biologics and biosimilars of diverse nature; peptides, complex glycoproteins (incl. mabs) and more recently cell-based therapies.
Qualifications: BSc (Hons) and PhD in Microbiology/Biotechnology, University of Surrey, UK
Femke Van Bockstaele
Program Lead
Femke Van Bockstaele
Program Lead
Femke is an experienced CMC expert with more than 10 years’ experience in biopharmaceutical drug development, focusing on CMC and regulatory aspects, and the interface between both. She held different positions at Ablynx (acquired by Sanofi), where she was instrumental to the successful EMA- and FDA-approval of Cablivi, the first commercially available Nanobody drug. Her core expertise lies in CMC strategy and technical writing, process validation and Module 3 writing (both for IND/IMPD as for BLA/MAA). She is a strong communicator and problem-solver, with a broad scientific knowledge, analytical mind and no-nonsense approach.
Qualifications: MSc Bio-engineering, PhD in Medical Sciences (both at Ghent University, Belgium)
Dervilia Grimes
Program Lead
Dervilia Grimes
Program Lead
Dervilia brings to Primecore over 15 years’ experience in the pharmaceutical industry with specific expertise in technical transfer, process development and optimisation, systems validation and operational excellence. Dervilia has a BSc. in Industrial Biochemistry and a diploma in Project Management. More recently she completed a MSc in Strategy and Innovation from National University of Ireland, Maynooth where she also received the school of business overall best performance award. Dervilia has worked on a number of small and large scale start up facility projects providing innovative solutions in facility design and operational excellence to deliver projects to global regulatory standards.
She was directly involved in regulatory inspections with the HPRA and FDA. Dervilia is a certified trainer and lectures in pharmaceutical manufacturing, quality risk management and systems validation at diploma and degree level.
Qualifications: BSc. in Industrial Biochemistry
Diploma in Project Management
MSc in Strategy and Innovation
Yvonne Kennedy
Program Lead
Yvonne Kennedy
Program Lead
Yvonne brings to Primecore over 25 years’ experience in the biopharmaceutical industry and significant technical, commercial and project management expertise in the development and commercialisation of oral and parenteral small molecule and biological products. Prior to joining Primecore Yvonne was the Vice President R&D Program and Portfolio Management, and Vice President Technical OperationsProject Management and Strategy at Horizon Pharma, overseeing project managers managing both early stage development projects, tech transfers for small molecule oral products and biologics in late-stage development and commercial settings. She was instrumental in developing and executing project planning systems, processes and tools and governance structures in constantly changing pharmaceutical development and operational environments.
At Alkermes Pharma she was the Senior Director, Head of Project Management, responsible for the planning, budgeting and tracking of development and commercial product support projects at the Athlone facility, Ireland. At Elan Drug TechnologiesYvonne held the position of Senior Director, Head of Project Management, and was responsible for planning, budgeting and tracking of development and commercial product support projects across 3 locations in Ireland and the US.
Qualifications: BSc. Hons degree in Biochemistry and Chemistry, PhD in Endocrinology from University College Dublin
Diploma in Accounting and Finance, ACCA
Strategic Capital Program Leadership
Helen Kelleher
Program Lead
Helen Kelleher
Program Lead
Helen is a highly experienced Program and Project Manager with over 25 years’ experience, who brings strong technical and people management capabilities to bear in her leadership of all aspects of capital program and project delivery. Helen is an excellent communicator and team leader with experience across a variety of Pharmaceutical areas and other high-tech industries, who has operated in the both the roles of owner and consultant Program or Project Manager. She has a background in Chemical Engineering and holds an MBA.
Qualifications: BE (Hons) Chemical Engineering
Chartered Engineer
Masters of Business Administration
Chris Colleton
Program Lead
Chris Colleton
Program Lead
Chris brings extensive experience as an Oral Solid Dosage Manufacturing Manager. He has 20 + years experience in the Pharmaceutical industry. Knowledge of all stages of tablet manufacture from Granulation through to tablet Printing/branding and automatic inspection.
He has spent a period in Japan investigating market complaints on finished colour coated printed tablets. Chris is conversant with Japanese quality standards. He has strong analytical ability and problem solving skills together with experience in identifying and implementing significant improvements in productivity, reducing manufacturing costs and inventory levels. Capable of forming and working in a team environment. He has an excellent record in people management and development.
Qualifications: Diploma in Supervisory Management, NCI
Claire Comerford
Program Lead
Claire Comerford
Program Lead
Claire is an Operations Leader with over 30 years’ experience of site operations with a global multinational in the Pharmaceutical and Biotech industry with a proven track record of delivering results and building capable teams. Her expertise spans Plant start up, Technical Transfer, Operations, Compliance, Planning and Program Management. Experienced in a network role, Claire has been responsible for the successful deployment of transformational programs at a number of sites, delivering sustainable improvement through the adoption of new ways of working and embedding a continuous improvement culture.
Claire is an excellent communicator and relationship builder with a collaborative inclusive approach and a talent for managing change.
Qualifications: BSc Industrial Design
Finance & Operations
Marian Walsh
Project Controls Lead
Marian Walsh
Project Controls Lead
Marian is an experienced project controls manager with a background in a number of Public Sector bodies and in Commercial, Residential, Industrial and Life Sciences sectors.
Marian and has over seventeen years experience in the areas of project management, cost engineering, scheduling, estimating, sub-contracts management, validation planning & field engineering. Marian’s experience extends to commercial / retail development, residential, office, bulk chemical, pharmaceutical, sterile production facilities and laboratory projects.
Marian has worked in Ireland, UK, France, Spain and Puerto Rico, USA, overcoming various different cultural and language barriers to achieve excellent project results.
Qualifications: Bachelor of Science In Construction Management WIT
CSCS (Construction Skills Certification Scheme) (Health & Safety)
Institute of Project Management Ireland
Patrick O’Neill
FINANCE & OPERATIONS COSTS
Patrick O’Neill
FINANCE & OPERATIONS COST CONSULTANT
Patrick has extensive experience in financial management for pharmaceutical manufacturing in US, Europe, Latin America and Asia Pacific. Specific expertise in product costing, budgeting, capital management, internal auditing, merger integration of Plants and strategy development for manufacturing division. Recognized for leadership in managing, developing, motivating and promoting 40+ staff in financial services. Four years of Animal Health experience focused on sales and customer service support for a $550M business, supply chain optimization and branding a new entity. Proven record of success in managing merger synergy savings and long term strategy goals while driving change management using Six Sigma tools. Holds both US and European passports.
Qualifications: Bachelor of Commerce, University College, Dublin, Ireland
Cyril O’Mahony
FINANCE & OPERATIONS
Cyril O’Mahony
FINANCE & OPERATIONS COSTS CONSULTANT
Cyril has 25 + years experience as a Finance Director with strong operational and commercial experience implementing capital intensive strategic change.
A highly effective team leader, an excellent communicator, results driven, excelling in high standards of management. He has provided Financial oversight of capital investments on behalf ‘Greenfield’ Capital Projects – €600M – Largest single capital investment project undertaken by US pharmaceutical company outside of the US. Cyril has implemented effective project control systems at Irish sites and ensured that a steadfast reputation was earned for delivering projects on time and within budget.
Qualifications: Member of the Institute of Chartered Accountants in England & Wales