Senior Manager Pharmaceutical Technology | Collins McNicholas

Senior Manager Pharmaceutical Technology

  • Reference: GY43029
  • Job Type: Permanent
  • Location: Galway city, Mayo, Sligo
  • Category: Science, Pharmaceutical & Food

Responsible for:Members of Pharm Tech group (small molecule), proposed headcount 5 people

Position Summary:

The Pharm Tech Manager is responsible for providing technical and process support for existing pharma products and new products introduced to the Westport campus.  The position is responsible for tech transfer, process scale up, process monitoring and troubleshooting.  The position requires cross-functional collaboration with the site Business Units and Project Management function in addition to the Global Pharm Tech group in order to provide site leadership in support of product manufacturing and new product implementation.  The production provides guidance and direction to Pharm Tech staff in their daily responsibilities and ensures the function operates in compliance with all quality regulations and Corporate Policies. The position has a direct reporting relationship to the Director of Pharm Tech based at the Westport site.

Overall Objectives of the Role:

Manage and lead a team responsible for the following:

  • Providing technical leadership in the management of multiple projects covering NPI, scale-up, Tech Transfer, process Validation, Process Robustness and site technical Investigations
  • Lifecycle management of a portfolio of products, from process engineering to scale up and transfer, including launch products
  • The application of statistical process assessment and control techniques
  • The execution of projects that will improve product quality, supply and reliability
  • Leading and executing complex technical projects
  • Providing the technical review for site change controls as it relates to potential product quality impact
  • Execute projects for the evaluation and implementation of new sources of APIs and critical excipients as well as change management for raw materials

Position responsible for:

  • Providing leadership and direction for Pharm Tech activities and integrate the function in to the wider plant operation ensuring it meets customer needs
  • Scheduling activities for the Pharm Tech team members, resolving project conflicts, ensuring resource allocation is adequate and correctly applied
  • Point of contact for technical support of the Westport small molecule product portfolio
  • Guiding the development of the site process validation strategy using the appropriate risk mitigation approach for NPI or existing products being enhanced and maintained
  • Generation and oversight of the budget related to group project activity – combining operations and R&D spend
  • Managing relationships with technical support functions on site and across the network
  • Providing technical support during the implementation of new process technologies, automated control systems and risk assess any impact to product quality
  • Providing leadership in statistical methodologies
  • Directing cross functional team for the resolution of investigations related to laboratory OOSs and process deviations for marketed product.  Ensuring expertise is provided to help solve difficult technical problems and coach personnel in problem solving for technical issues.
  • Defining the process validation requirements resulting from new equipment or proposed equipment changes.
  • Liaison between the Westport site and development teams to ensure efficient tech transfer and NPI, work to influence the development process to deliver design for products with optimised manufacturing processes.
  • Identifying and executing projects that will help achieve the goals of GPT
  • Leading site risk assessments for new product implementations and assess site launch capabilities
  • Ensure that the project knowledge milestones are executed and documented thoroughly

Position Qualifications:


  • Third level degree in process/chemical engineering or equivalent


  • Minimum of 10 years’ experience of development and manufacturing in the Pharma industry 
  • Process expert with knowledge and hands on experience of process engineering, preferably including liquid fill finish
  • Understanding of FDA/EU, ICH and USP requirements for Drug Product development and manufacturing
  • Experience in aligning teams and individuals to business objectives
  • Working knowledge of Lean Six Sigma and good statistical  application
  • Track record of Process Validation implementation for new EU and FDA Guidelines within a commercial facility.


  • Demonstrated experience applying sound and critical reasoning to troubleshooting complex process challenges
  • Proven track record as it relates to innovation and continuous improvement
  • Demonstrated ability to manage multiple projects under challenging conditions while maintain necessary focus on key objectives
  • Demonstrated ability to make logical, well-informed and timely decisions including risk analyses where relevant to evaluate short and long term impact and consequences of potential
  • Established high standards of performance , holding self and others accountable for results and confronting
  • Ability to recruit, develop and retain a high quality workforce and grow capability within the organisation

For a confidential discussion on this role please contact Amy O’Neill on 091-706718 or email:

For further information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website at

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Amy O’Neill

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
  • Connect with Amy

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