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Associate Director, Manufacturing

Location: Dublin, Republic of Ireland
Salary: Negotiable
Posted: 6 months ago
Role type: Permanent
Industry: Science, Technology and Operations Practice (STO), Supply Chain and Operations Leaders & Specialists
Contact name: Ciaran McCaughey
Contact email: ciaran.mccaughey@hrmrecruit.com

Job description

Our client is a start-up Pharma/Biologics manufacturing organisation. Due to a recent acquisition and new product introductions, they are seeking a technically astute highly motivated self-starter to join their organisation based out of their Dublin office.

The role:

  • You will oversee commercial manufacturing activities and development activities at contract manufacturers and contract labs.
  • Maintain effective coordination and on-time execution of complex activities at multiple locations on the critical path to regulatory submissions and launch.
  • The Senior Manufacturing Manager/AD will act independently to determine methods and procedures on new assignments and may provide guidance and oversee the activities of other support personnel.
  • Contribute to effective specification development of starting materials, chemical intermediates and drug substance/product.
  • You will be required to provide some support to CMC & deviation reviews while actively participating in development project teams and new Regulatory filings and updates.
  • Communicate with Quality Control/Quality Assurance, and Regulatory Affairs to facilitate the maintenance of commercial compounds and the development of candidate compounds and products.
  • Review regulatory submissions including analytical procedures, method validations, reference standards, batch analyses, product characterization, stability and specification sections.
  • Ensure compliance with all relevant GMP requirements.

The person:

  • You will be BSc or MSc qualified with experience and knowledge of development, scale-up and commercialisation of pharmaceutical large and small molecules.
  • Have a working knowledge of cGMP and ICH regulatory guidelines with experience in transfer and validation guidelines.
  • You will be a strategic thinking professional with competent use of software applications and statistical applications.
  • A high energy individual who exercises judgement in selecting methods, techniques and evaluation criteria for obtaining results.
  • A natural leader with a proven track record in coaching and people development.

The Benefits

  • Competitive base salary
  • Bonus
  • Healthcare
  • DC Pension

To learn more, apply online or contact Ciaran McCaughey on +353 16321830 for a confidential discussion.

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Ciaran McCaughey

Director - Supply Chain, Operation & Technology

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