We are currently looking for a highly motivated Senior Analyst in the Pharmaceutical Development area, to join us for a position in our site in Verona. He/She will work in a qualified team within the Analytical Science and will be responsible to:
Provide analytical support to the variouse phases of drug development, from API synthetic route scouting to drug product formulation development/optimization.
Develop and validate analytical methods for API (mainly small molecules) and drug products (mainly solid oral formulations) characterization.
Performance analytical testing according to standard operating procedures for batch release and stability studies.
Develop new methods of analysis for API and Drug products (e.g.: HPLC-UV methods for assay and impurities determination uniformity of content, enantiomeric purity; dissolution methods for drug product release profile determination).
Write analytical methods validation protocols in accordance with ICH guidance and internal guidelines for early and late phase projects.
Execute the validation method exercise following an approved protocol and timely report the obtained results in a validation report.
Write and/or review scientific and technical documentation, with the full accountability for the data presented and the comments/conclusions driven.
Perform characterization tests for formulation development prototypes to support stressed stability studies, DoE experiments, compatibility studies, etc.
Perform and review analytical determinations on final drug substances and drug products, following the appropriate documentation (analytical method, specification, protocol, stability protocol).
Correctly and timely report the generated data, according to the data integrity principles.
Ensure the traceability of all analytical operations conducted according to the GMP.
Establish/control analytical working standards.
Provide technical/practical training to new staff.
Promptly report out-of-specification data (OOS), out-of-trend data and anomalies to the laboratory manager or the Quality Control Manager, according to the specific SOP.
Check finished product analysis certificates for clients and finished product primary and secondary labels.
Draw up/revise analysis methods.
Draw up/revise technical and operational procedures.
Degree in Chemistry, Chemistry and Pharmaceutical Technology or similar. MS and/or PhD will be considered a plus.
Good written and spoken English.
Office suite/chromatographic data systems (CDS – e.g. Empower).
At least 5 years of work experience in the analytical sector of API/Drug Product development and/or manufacturing, in Pharmaceutical companies and GMP environment.
Excellent knowledge of chromatographic techniques (i.e. HPLC-UV) and dissolution, for both analyses execution and method development.
Good analytical, interpersonal and teamwork skills, precision and flexibility.
Ability to manage activities with tight deadlines and high matrix complexity.
Consistent and reliable approach to work, diligent and precise management of activities.