Manager/Senior Manager Pharmaceutical Development R&D
Our client, a global pharmaceutical organisation based in Waterford are currently recruiting for a Manager/Senior Manager of Pharmaceutical Development to join their R&D team. The ideal candidate will have experience in respiratory product development or a related area, excellent project management skills and experience in chemometrics/multivariate data analysis.
• Lead internal and external teams to develop robust combination drug products and associated processes intended for clinical studies and technical transfer to commercial operations
• Be the technical specialist in the development of inhalation formulations employing QbD principles; critically reviewing data and making recommendations on next steps
• Use chemometrics/multivariate data analysis plus material characterisation to analyse data, propose and validate models, solve problems and make robust conclusions to drive technical decisions
• Comply with, create and review R&D SOPs. Develop and review batch records, processes, validation reports and investigation reports. Work within site GMP requirements.
• Work with cross-functional departments such as Manufacturing, QC, QA, Regulatory Affairs and Operations to address deficiencies, fillings of new drugs plus ensure project development files are complete and accurate
• Ensure technologies are developed and validated to appropriate scale and transferred into manufacturing operations
• Effective and timely written and verbal communication.
• Contribute to production of Module 3 regulatory submissions and associated correspondence with regulatory agencies
• Preferably a Doctorate or Masters qualification in chemistry (or related subject) and at least 5 years’ industry experience in pharmaceutical product development. Hands on experience of leading a project within the respiratory field would be an advantage
• In depth understanding of the unique challenges associated with the development of combination drug products. Specific knowledge of particle engineering would be a distinct advantage
• Strong Chemometrics/Multivariate Data Analysis skills
• Ability to conceptualize ideas, motivate and focus individuals
• Proven project management, planning and influencing skills
• Knowledge of global regulatory and compliance requirements
• Knowledge of the IP and competitive landscape of device and drug delivery technologies would be an advantage
• Experience of working to current Good Manufacturing Practice and/or Good Laboratory Practice and implementing policies and procedures in line with regulatory guidelines
• Strong verbal and written communication; collaboration and team building skills
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252