A Senior Manager of Pharmaceutical Development is required by CareerWise Recruitment for our Waterford based multinational pharmaceutical client.
A leading multinational currently has an opportunity to join their expanding team.
Role of this position
- 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
Please call Michael Hanrahan today for further information on 021-2019817 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.