Pharmaceutical Development Laboratory Analyst - Mendrisio site (Ticino)

Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.
We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.

To strengthen our Pharmaceutical Development team at our headquarter in Mendrisio (Switzerland), we are currently looking for a Pharmaceutical Development Laboratory Analyst.

Position Summary

The main activities will be the execution of chemical analyses on finished products within the Stability Group of the Pharmaceutical Development Laboratory. Other activities will be the execution of experiments and analysis related to pharmaceutical development projects as well as participation in the validations and transfers of analytical methods. He/She will operate under the direct coordination of the Pharmaceutical Development Laboratory Manager and in collaboration with the other people working in the R&D Laboratory team and in the Pharmaceutical Development Department which the R&D Laboratory is part of.

Key responsibilities

• Analytical control of APIs and finished products under development.
• Execution of in-use stability studies (photostability, freeze-thaw, compatibility with contact surfaces, etc).
• Instrumental analysis executions (HPLC, UPLC, GC, UV-Vis, IR, pH, Karl Fisher, particle size, titrator, densimeter, osmometer).
• Data analysis and interpretation.
• Support the galenical development of new formulations (aqueous injectables, ophtalmic gels, etc).
• Stability studies and related changes or requests from regulatory authorities.
• Editing of SOPs, Batch Records and CoA.

Qualifications and skills

• Bachelor or Master’s Degree in scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry).
• At least 3 years of post-degree work experience, including at least 2 years in a Pharmaceutical Laboratory.
• Familiarity with both small and macro-molecules API.
• Strong theoretical and practical knowledge of principal analytical instruments as HPLC, GC, UV, FT-IR.
• Knowledge and previous use of technical tools for QbD such as Design of Experiments statistical software will be considered an asset.
• Proficiency in the use of multiple instrument platforms (e.g. Agilent, Thermo Fisher Scientific, etc.) and laboratory software applications (e.g. Chromeleon CDS, Labware LIMS systems).
• Attitude to accurately compile and record data for documentation needed for testing and reports preparation.
• Familiarity with FDA/EMA regulations, Pharmacopeias (USP/EP/BP) and ICH quality guidelines (specifically Q1 through Q3).
• Strong GMP and regulatory compliance knowledge.
• Excellent command of written and spoken English.
• Strong organizational skills and high level of precision in both experimental execution and technical writing.
• Ability to interpret complex data sets and troubleshoot "out of specification" (OOS) or "out of trend" (OOT) results.
• Able to communicate effectively and maintain effective working relationships.
• Self-motivated, positive and ability to work under pressure.
• Demonstrates a continuous improvement mind-set.

We offer

Fulltime permanent employment in a young working environment and positive culture.
Sintetica promotes diversity and gender equality.