A Global Multinational Company headquartered in Italy is seeking an enthusiastic and self-motivated individual who would be interested in working as a Unit Head to manage their Analytical Unit. Reporting to the Drug Product Development Dept Head, you will be responsible for the development and validation of analytical methods and for the Drug Product analytical characterization.
You will manage and develop a team of professional laboratory technicians and scientists, ensuring that their technical skills are always aligned with the needs of the projects. You will also support the Department Head in the definition of department budget (including human and economic resources).
Responsibilities:
–Development and Validation of Drug Substance (DS) & Drug Product (DP) analytical method;
–Transfer the analytical methods to R&D QC;
–Identify the Critical Quality Attributes for both Drug Substance and Drug Product (including interaction with device and CCS), for the appropriate definition of critical specifications and related scientific justification;
–Ensure that DS/DP characterization are conducted in accordance to Company SOPs and protocols and with cGMP/ICH where applicable;
–Ensure that all laboratory documentation is completed according to company standards including all relevant investigations;
–Ensure a continuous innovation of the analytical technologies, in order to keep a high level and excellence of scientific know-how.
With a Ph.D. or M.Sc. in Pharmaceutical Analysis and at least seven years of relevant pharmaceutical & analytical development experience in a well structured company, the ideal candidate has got an international experience, strong knowledge of modern analytical techniques and development of different pharmaceutical forms, good understanding of analytical method development & validation requirements of pharmaceutical industry for new chemical entities development, a good theoretical knowledge of chromatographic sciences and spectroscopic technologies e.g. UV, IR, MS, NMR, XRD. Strong knowledge of characterization techniques in physical and aerodynamic properties, chemical and solid state stability (i.e. crystallinity, polymorphism).
Strong knowledge about Drug Substance/Excipients compatibility studies and good understanding of cGMP, ICH and FDA requirements. Additional experience in pharmaceutical dosage forms for pulmonary delivery, i.e. Pressurized Metered Dose Inhalers (pMDI’s), dry powder inhalers (DPI), liquid-nebulizers (UDV)] could be relevant.
The right candidate is a scientific & flexible, target oriented manager with interdisciplinary success and scientific problem solving attitude who works well independently and in a team environment and who is willing to develop scientific networking interacting with advanced CROs/academia. Determination and ability to lead organisational and cultural (i.e. scientific and innovation) change are essential.
Ability to determine the right balance between minimal efforts required for rapid progress to POC and needs for thorough long term development will be an every present challenge for this position.
Fluent in English, outstanding communication skills are required.
If you are interested in this new, exclusive career opportunity, please email your application to sergio.carito@secpharma.com or call Sergio Carito on +44 207 255 6600.
