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.
- 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.
- 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.
- Competitive base salary
- DC Pension
To learn more, apply online or contact Ciaran McCaughey on +353 16321830 for a confidential discussion.