Senior Scientist, Pharmaceutical Development

Senior Scientist, Pharmaceutical Development

Evotec

Verona, Italy

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.

Responsibilities:

  • 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.

Requirements:

  • 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.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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