Main Duties & Responsibilities:

- Participate in the development of analytical procedures in support of pharmaceutical product development projects

- Ensure that analyses of experimental and stability samples are conducted strictly in accordance with cGMP, Company's SOPs and protocols

- Ensure that all ED laboratory documentation is completed to the highest quality standards and that any formal investigations e.g. Out of Specification (OOS), Change or Deviation Data are conducted promptly and thoroughly

- Convey results of analytical studies and participate in project discussions within teams

- Help DH to make recommendations for additional personnel and equipment resources that might be needed to meet our project commitments

- Keep up to date with advances in analytical, pharmaceutical and regulatory

- Complex chemical and physical analysis on the full range of analytical samples in accordance with established procedures to support product submissions and product claims

- Pre-formulation studies in order to provide data on APIs that will lead to development of suitable pharmaceutical products

- Develop and strengthen Unit capability in new methods or for conducting novel analytical studies or investigations

- Manage the schedules for each scientist in the ED to ensure that studies are completed in accordance with project timelines and expectations


Requirements:

- Ph.D. or M.Sc. in a science related to Pharmaceutical Analysis

- 5-6 years of pharmaceutical analytical development experience in industry

- Good understanding of analytical method validation requirements of pharmaceutical industry

- Good understanding of the chemistry of pharmaceutical APIs and of analytical techniques for their characterization

- Candidates must have a good theoretical knowledge of chromatographic sciences and spectroscopic technologies e.g. UV, IR, MS, NMR, XRD

- Very positive interests in keeping up to date with new technologies and developments in analytical sciences

- Good understanding of cGMP, ICH and FDA requirements

- Fluency in English, both written and spoken. A second European language would be an advantage, Italian is preferred.


If you would like to discuss this role in greater details or your application/suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on.