Sintetica

Laboratory Pharmaceutical Development Project Manager - 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 Laboratory Pharmaceutical Development  Project Manager.

 

Position summary

The Laboratory Pharmaceutical Development Project Manager will manage projects related to:

  • Analytical methods Development and Validation
  • Galenical development of new sterile drug products and ophthalmic products
  • Optimization of formulations related to sterile liquid and semi-solid drug products already in place.

He/She will operate under the direct coordination of the Pharmaceutical Development Laboratory Manager and in collaboration with the other people working in the laboratory team and in the Scientific Affairs Department which the laboratory is part of.

 

Essential tasks and responsibilities

  • Coordination and support of the activities related to the assigned project.
  • Collaboration with the other Scientific Affair’s departments and with QC and QA to reach the project goal.
  • Set up and comply with the planning for the project output.
  • Identify and interpret regulations and guidelines issued by applicable regulatory agencies and other regulatory organizations.
  • Improve galenical development and analytical knowhow by attending courses, seminars and meetings.
  • Support the digitalization process of the laboratory (implementation of a new LIMS and ELN software)
  • Perform other duties as directed.

 

Required skills and core competences

  • Bachelor’s degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry).
  • Previous experience in pharmaceutical company or similar.
  • 6 years of post-degree work experience, including at least 4 years in a research and development context.
  • Familiarity with ICH/EU/US/Swiss laboratory guidelines related to the technical subjects as analytical methods validation, extractable & leachable, nitrosamine, stability and photostability studies.
  • Good English communication and writing skills.
  • Expertise in UHPLC method’s development and validation.
  • Attitude to compile and record data for documentation needed for testing and reports preparation.
  • Knowledge of regulatory compliance with GLP and GMP environment.
  • Experience in the design / execution of Extractables and Leachables studies will be considered an asset.
  • Experience in implementing a digital transformation of the laboratory will be considered an asset.
  • Proactivity, autonomy, precision, good teamwork skills, excellent planning skills, meeting deadlines, good stress management, and ability to cope with tight schedules.
  • Analytical thinker with strong problem-solving skills and the ability to resolve conflicts and develop a course of action leading to beneficial outcomes.
  • Commitment to continuous improvement.

 

We offer

Fulltime permanent employment in a young working environment and positive culture.

Sintetica promotes diversity and gender equality.

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