Summary
Work history
Skills
Custom
Affiliations
Accomplishments
Timeline
Generic

James Byrne

Dublin

Summary

An enthusiastic and authentic leader with 25+ years of experience in the pharmaceutical industry gained across a wide variety of operational roles at Horizon Therapeutics, Ipsen and Bristol Myers Squibb. Expertise in leading business transformations, building high performing and high trust teams, creating a strong shared vision, mission and values for organisations. Known for being a strong collaborator, a team player and for achieving exceptional results. Experience in large molecule DS and DP, small molecule API, peptides and external manufacturing.

Work history

Executive Director of Manufacturing Operations

Horizon Therapeutics now part of Amgen
  • Leading the Horizon External Manufacturing team with responsibility for Horizon’s large and small molecule manufacture portfolio consisting of four large molecules and six small molecules across over 20 CMOs, with global sales of approx
  • $4 billion
  • Led the successful expansion of TEPEZZA (monoclonal antibody) manufacturing at both the drug substance and drug product CMOs to meet the rapid growth in demand – launch to $2 billion in two years
  • Improved yields of TEPEZZA DS at commercial scale by +35% over three years at our CMO
  • Successfully achieved 100% delivery of all finished products for past three years ensuring 100% of patients received their medicines on time
  • Led the manufacturing and tech transfer preparation for Horizon’s new Waterford facility until the new management team was onboarded
  • Provided manufacturing expertise for the due diligence team for the acquisition of the DP manufacturing site from Eirgen
  • Reorganized cross-functional product delivery teams to improve collaboration and results.

Vice President Global Engineering and Technology

Ipsen
  • Led the Global Engineering function with responsibility for managing global capital expenditure (€250 million budget), factory of the future technology and for leading major projects
  • Led strategic portfolio review of Ipsen capital investments as part of cost cutting measures, identifying synergies and savings across the group enabling >40% reduction in investments
  • Carried out a review of a key strategic project reorganising, de-risking and re-programming to ensure on time and on budget delivery of a new manufacturing facility in France to enable the successful transfer of a key product from the USA to France
  • Led concept design for sterile liquid fill and lyophilised drug product manufacturing facility at Ipsen Wrexham
  • Developed “Factory of the Future” roadmap for the global tech operations group
  • Identified and implemented suitable “FOF use cases” as well as key technologies including MES and advanced automation solutions across the Ipsen’s manufacturing sites.

Vice President Ipsen and Site Head Dublin

Ipsen Manufacturing Ireland Ltd
  • Ipsen Manufacturing Ireland site is responsible for the API production for Ipsen's number one and two products which have combined sales in excess of €1.5 billion
  • Employing 160 people I had full responsibility for leading the Ireland site
  • Managed the rapid capacity increase required to handle 30% year on year growth for Ipsen’s top product Somatuline with sales increasing from €250 million to €1.2 billion
  • Led €180 million investment program totally transforming the site in all aspects with all major projects completed on time and budget
  • Projects included five new lyophilisers and extensive downstream chromatographic purification units and associated buffer makeup vessels as well as new peptide API synthesis
  • Led the implementation of Behavioural Based Safety program on site which resulted in seven years without a lost time accident
  • Achieved ISO 14001 and OSHA 18001 certification in 2018
  • Led strong communication strategy within organisation to build high trust and engagement across all levels in the company and enable the business to achieve its goals and objectives
  • Achieved highest engagement score of all Ipsen sites and offices in biannual global survey
  • Achieved Great Place to Work Status for Dublin in 2018 and in 2019 achieving thirteenth and eighth place respectively for medium size companies in Ireland
  • Proven track record of leading successful FDA and HPRA inspections, well networked and expertise in regulatory affairs as well as extensive experience in dealing with the EPA
  • De-risked operations at Dublin and achieved highest possible Factory Mutual risk score (87 out of 87), which is critical for the Dublin site as it is the sole source supplier of APIs for Ipsen's top two products
  • Led the Dublin site to achieve Shingo silver level as assessed by Manufacturing Institute
  • Improved the yields of Ipsen #1 product by over 40%.

Head of Operations

Ipsen Manufacturing Ireland Ltd
  • Responsibility for leading Production, Process Support, Engineering & Maintenance, IT, EHS, Supply Chain and Operational Excellence departments
  • Reorganised the Operations function - set up process engineering dept., implemented PMBOK system for managing capital projects, reorganised production department, expanded the responsibility of purchasing dept
  • Led the implementation of Lean and Six Sigma on site introducing a culture of continuous improvement
  • Repositioned safety on site, implementing new health and safety management system and made safety a top priority for everyone.

Technical Services Manager

Bristol Myers Squibb - Cruiserath
  • Responsible for operation of all end of line treatment systems including incinerator (the largest incinerator in Ireland), solvent recovery units, biological wastewater treatment systems, cryogenic unit and for the management of all tank farm operations
  • Improved the performance, reliability and efficiency of Tech Service operations which were critical to successful manufacturing on site as part of EPA licence; achieved very significant improvements in MTTR, MTBF and cost reduction of >20% on operating budget of $12 million.

Production Manager

Bristol Myers Squibb - Cruiserath
  • Led the recruitment and training of 45 manufacturing technicians and shift managers
  • Led the start-up of the manufacturing facility leading to successful validation campaigns and FDA and HPRA inspections.

End User Team Lead for new $500 million Cruiserath facility

Bristol Myers Squibb - Cruiserath
  • Led the overall design layout, major equipment and technology selection for the manufacturing building
  • Led the commissioning and qualification of the manufacturing facility.

P4 (Taxol) Plant Manager

Bristol Myers Squibb – Swords Laboratories
  • Responsible for the scale up and production of BMS’ main anticancer drugs including Paclitaxel
  • Managed rapid growth of Paclitaxel from $30 million to $1.5 billion in sales over a 4 year period.

Project/ Process Engineer

Bristol Myers Squibb – Swords Laboratories
  • Reporting to the Project Manager, I was involved in all aspects of the design, construction and commissioning of the P4 anticancer manufacturing facility
  • Led the process design as well as the design, testing and commissioning of the automation system resulting in successful start-up of BMS’ first high containment, highly automated manufacturing facility.

Skills

  • Leadership
  • Transformation
  • Project Management
  • Collaboration
  • Strategic Planning
  • Change Management
  • Risk Management
  • Problem solving
  • Communication
  • Innovation
  • Green field / start-up
  • Resilience

Custom

  • Board member of BiopharmaChem Ireland (BPCI)
  • Lead representative for Ipsen at Biophorum
  • Member ISPE
  • I enjoy sailing, golf and gym

Affiliations

  • golf, gym and sailing

Accomplishments

achievement number1

Timeline

Vice President Global Engineering and Technology

Ipsen

Vice President Ipsen and Site Head Dublin

Ipsen Manufacturing Ireland Ltd

Head of Operations

Ipsen Manufacturing Ireland Ltd

Technical Services Manager

Bristol Myers Squibb - Cruiserath

Production Manager

Bristol Myers Squibb - Cruiserath

End User Team Lead for new $500 million Cruiserath facility

Bristol Myers Squibb - Cruiserath

P4 (Taxol) Plant Manager

Bristol Myers Squibb – Swords Laboratories

Project/ Process Engineer

Bristol Myers Squibb – Swords Laboratories

Executive Director of Manufacturing Operations

Horizon Therapeutics now part of Amgen

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James Byrne