James Byrne

James Byrne Email and Phone Number

Executive Director of Manufacturing Operations | Pharmaceutical Executive | Site Leader | Proven People and Technical Leader | Transformation Expert | Driving Efficiency and Innovation in Pharma Operations @ Amgen
James Byrne's Location
Ireland, Ireland
James Byrne's Contact Details

James Byrne personal email

n/a
About James Byrne

A dynamic and results-driven leader with extensive experience in the pharmaceutical industry, having held key strategic and operational roles at Horizon Therapeutics, Ipsen, and Bristol Myers Squibb. Proven expertise in driving business transformations and fostering high-performing, trust-centered teams. Known for a collaborative approach, strong teamwork, and a track record of delivering exceptional results. Experienced in managing large molecule drug substance (DS) and drug product (DP), small molecule active pharmaceutical ingredients (APIs) and peptides as well as experience in leading external manufacturing operations.SkillsLeadership, Communication, Strategic Planning, Transformation, Change Management, Innovation, Project Management, Risk Management, Green field / start-up, Collaboration, Problem solving, and Resilience

James Byrne's Current Company Details
Amgen

Amgen

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Executive Director of Manufacturing Operations | Pharmaceutical Executive | Site Leader | Proven People and Technical Leader | Transformation Expert | Driving Efficiency and Innovation in Pharma Operations
Website:
amgen.com
Company phone:
+ 0120-790-549
James Byrne Work Experience Details
  • Amgen
    Executive Director Of Manufacturing Operations (Rare Disease)
    Amgen Oct 2023 - Present
    Thousand Oaks, Ca, Us
  • Horizon
    Executive Director Of Manufacturing Operations At Horizon Therapeutics
    Horizon 2021 - Present
    Dublin, Ireland, Ie
    Leading the Horizon External Manufacturing team with responsibility for Horizon's large and small molecule portfolio consisting of four large molecules and six small molecules across over 20 CMOs, with combined 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• Successfully achieved 100% delivery of all finished products for past three years ensuring 100% of patients received their medicines on time• Led the tech transfer preparation for Horizon's new Waterford facility until the new Waterford management team was onboarded• Reorganized cross-functional product delivery teams to improve collaboration and results
  • Ipsen
    Vp Global Engineering And Technology
    Ipsen 2019 - 2020
    Boulogne Billancourt, Fr
    Led the Global Engineering function with responsibility for managing global capital expenditure (€250 million budget) and factory of the future roadmap and implementation. • 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• Led the design for a new 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• Streamlined capex approval process and introduced new monthly KPIs and reporting for capital projects.• Implemented a global maintenance efficiency program with savings identification of >20% of maintenance expenditure.
  • Ipsen
    Vice President Ipsen, Site Head,
    Ipsen 2011 - 2019
    Boulogne Billancourt, Fr
    •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 €150 million investment program totally transforming the site in all aspects and a further €30 million investment under way with all major projects completed on time and budget.•Led the implementation of Behavioural Based Safety program on site which resulted in 7 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. Implemented extensive Tier system for managing day to day operations. Strong focus on problem solving and delivering on aggressive productivity and efficiency savings. Improved the yields of Ipsen #1 product by over 40%.
  • Ipsen
    Head Of Operations
    Ipsen 2007 - 2011
    Boulogne Billancourt, Fr
    •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.
  • Bristol Myers Squibb
    Technical Services Manager
    Bristol Myers Squibb 2005 - 2007
    Lawrence Township, Nj, Us
    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%.
  • Bristol Myers Squibb
    Production Manager
    Bristol Myers Squibb 2003 - 2005
    Lawrence Township, Nj, Us
    •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.
  • Bristol Myers Squibb
    Leader -Bms End User Team
    Bristol Myers Squibb Oct 1998 - Jan 2003
    Lawrence Township, Nj, Us
    Lead BMS End user team through all aspects of Design (Concept, FED, DD) and start up on new $500 million API facility
  • Bristol Myers Squibb
    P4 Plant Manager
    Bristol Myers Squibb Jun 1993 - Oct 1998
    Lawrence Township, Nj, Us
    Managed the capacity increase of Paclitaxel production from sales of $30 million per year to over $1.5 billion in 4 years.

James Byrne Skills

Leadership Authentic Lean Manufacturing Integrity Budget Gmp Chemical Engineering People Development Start Ups Communication Strategic Planning Strategy Quality System Emotional Intelligence Resilience Cross Functional Team Leadership Change Management Collaboration Operational Excellence Project Management Lean Six Sigma Pharmaceutical Industry Problem Solving Transformation

James Byrne Education Details

  • University College Dublin
    University College Dublin
    Chemical Engineering
  • Irish Management Institute
    Irish Management Institute
    Diploma In Management
  • Productivity Group Europe
    Productivity Group Europe
    Lean Six Sigma Green Belt

Frequently Asked Questions about James Byrne

What company does James Byrne work for?

James Byrne works for Amgen

What is James Byrne's role at the current company?

James Byrne's current role is Executive Director of Manufacturing Operations | Pharmaceutical Executive | Site Leader | Proven People and Technical Leader | Transformation Expert | Driving Efficiency and Innovation in Pharma Operations.

What is James Byrne's email address?

James Byrne's email address is ja****@****com.net

What schools did James Byrne attend?

James Byrne attended University College Dublin, Irish Management Institute, Productivity Group Europe.

What skills is James Byrne known for?

James Byrne has skills like Leadership, Authentic, Lean Manufacturing, Integrity, Budget, Gmp, Chemical Engineering, People Development, Start Ups, Communication, Strategic Planning, Strategy.

Who are James Byrne's colleagues?

James Byrne's colleagues are Joanna Baker, Ben Brooks, Dabt, Nicholas Quinn, Omari Anson, Ao Santiwong, Mina Sabet, G V.

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