Steven Gallagher

Steven Gallagher Email and Phone Number

Director, Head of Americas and International Partner Markets @ CSL
Philadelphia, PA, US
Steven Gallagher's Location
Philadelphia, Pennsylvania, United States, United States
Steven Gallagher's Contact Details
About Steven Gallagher

Steve's career in pharma started as an Analytical Chemist in Drug Development. After attaining an MBA with an option in Biotechnology and Health Industry Management, he became a Brand Manager in Marketing and then a certified Lean Six Sigma Black Belt and trained Master Black Belt. Recently, Steve has deployed GxP RPA bots into production and is progressing the automation roadmap for CSL’s Pharmacovigilance department. In addition, he is responsible for project managing PV integrations through recent M&A.

Steven Gallagher's Current Company Details
CSL

Csl

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Director, Head of Americas and International Partner Markets
Philadelphia, PA, US
Website:
csl.com.au
Employees:
23400
Steven Gallagher Work Experience Details
  • Csl
    Director, Head Of Americas And International Partner Markets
    Csl
    Philadelphia, Pa, Us
  • Csl
    Director, Head Of Americas & International Partner Markets,
    Csl Nov 2023 - Present
    Melbourne, Victoria, Au
    Ensuring there is an appropriate global PV support and oversight framework for the Americas region of affiliates across all CSL business units (Behring, Seqirus, and Vifor) in complement to the overarching GSPV strategy and objectives in partnership with all GSPV functions. Responsible for senior stakeholder management across the CSL enterprise including but not limited to those in Commercial, Medical, Regulatory Affairs, and Quality.
  • Csl
    Pv Regions Launch Excellence & Risk Management Lead
    Csl Mar 2023 - Nov 2023
    Melbourne, Victoria, Au
    Creating and maintaining the strategic and operational framework for product safety management, communication, and governance in the affiliate network for all CSL business units.• Liaise with local affiliates to implement process for oversight of Hemgenix® aRMMs for global launch.• Ensures standardization and monitoring of safety signals and other safety relevant information. • Completed short-term international assignment in Zürich, Switzerland supporting the CSL Vifor Global Drug Safety integration
  • Csl
    Process Improvement & Innovation Lead
    Csl Sep 2018 - Mar 2023
    Melbourne, Victoria, Au
    Improving cross-functional processes and spearheading innovation for the Global Clinical Safety & Pharmacovigilance dept. within CSL Behring R&D.• Project managed the PV integration of Vifor Global Drug Safety. Based in CSL Vifor Zürich office February to May 2023. • Implement solutions to increase efficiency and drive down cost of adverse event reporting.• Supported Sr. VP of the PV dept. with effective decision-making, project management, and execution of strategic initiatives across his Leadership Team.• Execution of PV integrations (e.g. Vitaeris, Etranadez, Seqirus Regions, & Vifor), acting as a central driver of value, conflict resolution, and project management.• Facilitated the development of the strategic Automation Roadmap for PV Operations.• Project managed both the NLP for MedDRA Coding PoC and Pilot for Case Management.• Received "Impact Award" for collaborating with IT to co-create CSL's RPA Center of Excellence.• Managed team of RPA developers and launched 3 GxP validated bots into production environment.• Presented at various internal and external global conferences on CSL’s PV automation journey.• Managed & mentored multiple Drexel University co-ops and fostered their personal development.
  • Teva Pharmaceuticals
    Certified Black Belt & Trained Master Black Belt
    Teva Pharmaceuticals 2014 - 2018
    Tel-Aviv, Il
    Recipient of the 2017 Teva President's Club AwardCompleted TMAC Master Black Belt training, December 2, 2016Teva Certified Black Belt, April 25, 2016Teva Certified Black Belt (Sr. Manager) within the Continuous Improvement Dept. Leading multiple Lean Six Sigma projects and process mappings across Teva North America Specialty Medicines to improve processes, decrease costs, and/or increase revenue.
  • Teva Pharmaceuticals
    Associate Product Manager
    Teva Pharmaceuticals 2013 - 2014
    Tel-Aviv, Il
    • Developed tactics and strategies for the post-launch of Quartette®- Analyzed sales & Rx data to refine forecasting and assist with supply chain management- Planed, monitored, and managed marketing budgets for the brand- Performed U.S. market research; interviewing HCPs and patients- Rode with Sales Reps. across the country to gather insights and knowledge of the field• On December 2, 2013 was assigned as the lead brand manager for Quartette® and any future OC product launches.- Developed, implemented, and coordinated appropriate business plans and marketing activities to ensure quantitative and qualitative objectives were met- Worked with creative agencies on promotional pieces for in-line and pre-launch products- Managed multiple vendors at a time to align with goals of the brand
  • Teva Pharmaceuticals
    Strategic Marketing Intern
    Teva Pharmaceuticals Sep 2012 - Jul 2013
    Tel-Aviv, Il
    Part-time mentorship within Teva’s Global Medicines Insights Group.• Attended the 2013 Teva Marketing Research & Forecasting Summit and learned the newest methodologies that my Teva colleagues are utilizing to enhance insights and make business recommendations while increasing cost-efficiencies.• Observed several primary market research studies of HCPs and consumers across different therapeutic areas.• Participated in discussions with internal customers regarding the best approach and availability of market research resources to answer key business questions.• Leveraged clinical experience to provide insights and knowledge pertaining to the worldwide clinical trial process.• Provided executive summaries on global market size assessments and growth drivers from syndicated reports on therapeutic areas that are of interest to business development.
  • Vincodo
    Campaign Analyst
    Vincodo Apr 2013 - Aug 2013
    Langhorne, Pa, Us
    • Analyze Conflict Management - Search query analysis to drive negative keyword expansion and campaign structure refinement.• Campaign Maximization and Optimization - Campaign asset development including keyword and ad copy building. - Keyword level bid optimization to target campaign segment-specific efficiency goals. - Developed macros and analysis tool building to streamline spreadsheet manipulation.• Prepared and executed strategy for Enhanced Campaign account transitions
  • Cephalon
    Sr. Analytical Associate I
    Cephalon 2011 - 2013
    Us
    On October 14, 2011 Cephalon, Inc. was acquired by Teva, Ltd.• Provided analytical expertise for optimizing drug stability via Design of Experiments.• Detailed analysis of experiments using JMP statistical software.• Managed a student intern during summer 2012.In 2010 was reassigned to a two person team in charge of method development of biologics.• Bioanalytical support and method development provided to formulation development for antibodies, polypeptides, and other large molecules.• Provided method development expertise for bioanalytical HPLC methods such as HIC, SEC, and IEX.• Developed methods for capillary electrophoresis (cSDS & cIEF).• Provided analytical support for biologic testing using the following techniques: Viscometry, SDS-PAGE, UV concentration, and Raman.• Performed protein diafiltration and concentration techniques along with fraction collection of isoforms.• Performed aggregate analysis using DLS in conjunction with SEC and SDS-PAGE.
  • Cephalon
    Analytical Associate Iii
    Cephalon 2008 - 2011
    Us
    Worked within Analytical Development for the Chromatography Group and performed HPLC assays of various dosage forms. • Managed a student intern during summer 2010.• Provided method development & validation of new HPLC stability indicating methods for current & newly discovered API’s & formulations for transfer to QC. • Performed forced degradation studies in accordance with ICH guidelines.• Conducted multiple reconstitution/admixture studies for Treanda®. • Experienced working with injectables, oral liquid, and solid dosage formulations.• Used solid-state techniques such as Raman, particle size, XRPD, microscopy, Karl Fischer, and viscometry.• Experienced working in a GLP environment for analytical support of toxicology samples formulated in suspensions and in DMSO solutions. • Provided analytical support to the formulation development group and to quality control for OOS/OOT investigations and for IND/NDA filings.• Methods, development reports, and SOPs written routinely.• Familiar with cGxPs.
  • Cephalon
    Analytical Associate Ii
    Cephalon 2005 - 2008
    Us
    Hired as a full-time permanent employee within Analytical Development working for the Chromatography Group. • Provided analytical method development and support for extended release formulations.• Attended several training courses to build expertise in HPLC method development, API solid-state analysis & viscosity analysis.
  • Cephalon
    Pharmaceutical Chemistry Intern
    Cephalon May 2004 - Aug 2004
    Us
    Summer Internship in a pharmaceutical formulations lab working in the Drug Discovery Support group. • Performed research on particle size reduction of API using physical methods with dissolution, DSC, HPLC, optical microscopy and particle size measurement (micro and nano) for analysis. • Presented a PowerPoint presentation to colleagues and wrote an internal report on the research project. • Received Drug Development Achievement Award.

Steven Gallagher Skills

Biotechnology Analytical Chemistry Pharmaceutical Industry Drug Development Validation Drug Discovery Gmp Cross Functional Team Leadership Fda Protein Chemistry Product Launch U.s. Food And Drug Administration Lean Six Sigma Business Process Improvement Continuous Improvement Standard Operating Procedure Good Manufacturing Practice Strategy Jmp Brand Management Product Marketing Minitab

Steven Gallagher Education Details

  • Penn State Great Valley
    Penn State Great Valley
    Biotechnology & Health Industry Management
  • Villanova University
    Villanova University
    Chemistry

Frequently Asked Questions about Steven Gallagher

What company does Steven Gallagher work for?

Steven Gallagher works for Csl

What is Steven Gallagher's role at the current company?

Steven Gallagher's current role is Director, Head of Americas and International Partner Markets.

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What is Steven Gallagher's direct phone number?

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What schools did Steven Gallagher attend?

Steven Gallagher attended Penn State Great Valley, Villanova University.

What skills is Steven Gallagher known for?

Steven Gallagher has skills like Biotechnology, Analytical Chemistry, Pharmaceutical Industry, Drug Development, Validation, Drug Discovery, Gmp, Cross Functional Team Leadership, Fda, Protein Chemistry, Product Launch, U.s. Food And Drug Administration.

Who are Steven Gallagher's colleagues?

Steven Gallagher's colleagues are David Schirmer, Renee Green, Maria Gabriella Patrassi, Jürg Siegenthaler, Sandra Velasco, Ankit Batra, Cindy Mccarney.

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