Aptuit, Inc. Scientist / Sr Scientist, Analytical Development & Quality Control in Verona, Italy

Aptuit is a multinational R&D Pharmaceutical company (CRO) that provides integrated early discovery to mid-phase drug development solutions by applying scientific excellence, outstanding service and a team of some of the foremost scientific professionals in the industry.

We are currently looking for an AD&QC Senior Analyst in the Pharmaceutical Development group to:

  • Develop and validate analytical methods for API characterization (mainly small molecules) and drug products (mainly solid oral formulations)

  • Develop and validate analytical methods to support cleaning verification activities

  • Performance analytical activities according to standard operating procedures for batch release and stability studies

  • Develop new methods of analysis for the optimization of existing analytical methods received from the client

  • Prepare validation protocols, carry out the planned activities and write analytical method validation reports

  • Perform characterization tests for formulation development prototypes

  • Perform stress test studies

  • Perform product sampling activities during processing

  • Perform chemical and chemical / physical tests on raw materials, semi-finished products, active ingredients (API), finished products (Drug Product) and stable products

  • Necessary chemical and physical analysis for validation tests (process, mixing, ecc)

  • Manage purchased reagents and solutions prepared in the laboratory

  • Compile and archive analytical documentation

  • Ensure the traceability of all analytical operations conducted according to GMP

  • Establish / control analytical 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

  • Check finished product analysis certificates for clients and finished product primary and secondary labels

  • Prepare orders for consumable laboratory material

  • Check the availability of incoming laboratory consumables: conformity with the placed order

  • 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 – esp. Empower)

  • At least 5 years of work experience in the analytical sector for API/Drug Product, all in Pharmaceutical companies and GMP environment.

  • Good analytical, interpersonal and teamwork skills, precision and flexibility.

  • Consistent and reliable approach to work, diligent and precise management of activities.

  • European Union work permit

ID: 2015-3079

External Company Name: Aptuit, Inc.

External Company URL: http://www.aptuit.com/