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
External Company Name: Aptuit, Inc.
External Company URL: http://www.aptuit.com/