Sintetica

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 Pharmaceutical Development Project Manager.

 

Position summary

The Pharmaceutical Development Project Manager should have a chemistry/pharmaceutical background and will manage projects related to both:

  • New sterile drug products and ophtalmic products
  • Optimization of processes, presentations and formulations related to sterile liquid and semi-solid drug products already in place.

He/She will operate under the direct coordination of the Pharmaceutical Innovation Manager and in collaboration with the other people working in the Pharmaceutical Development team and in the Scientific Affairs Department which the Pharmaceutical Development is part of. He/She will follow the technical aspects of the projects starting from the “idea” until the creation of the results required in the CMC part (Module 3 and 2.3) of the related eCTD.

 

Essential tasks and responsibilities

  • Definition of the functional specifications of both formulation and final product considering the user requirement specifications identified in the design phase.
  • Identification of new pharmaceutical solutions for improving therapies.
  • Supervision of development and manufacturing activities.
  • Coordination and support of internal and external tasks related to the assigned projects.
  • Strong interaction with internal departments (R&D Lab, CMC, RA, Clinic, QA, QC, Supply Chain, Production) to reach the project goals.
  • Drafting of the documentation necessary for the correct management of the projects.
  • Travel (10-20% of total time) to supervise those activities performed in other Sintetica sites and with external partners.
  • Improve pharmaceutical development knowhow and GMP knowledge by attending courses, seminars and meetings.
  • Stakeholders and KOLs interaction.
  • Perform other duties as directed.

 

Required skills and core competences

  • Bachelor’s degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry, Industrial Pharmacy).
  • 8 years of post-degree work experience, 3 years in research and development project management.
  • Strong knowledge of GMP and GLP guidelines.
  • Experience in manufacturing and development of sterile injectable and semi-solid drug products. Experience on aseptic manufacturing and lyophilized products would be an asset.
  • Experience in eCTD CMC Part (Module 3 and 2.3) compilation and management.
  • Knowledge of ICH/EU/US/Swiss guidelines related to the technical subjects of manufacturing equipment and process validation, stability and photostability studies, elemental impurities, extractable & leachable, analytical methods validation.
  • Experience in project management tools such as MS Project and Smartsheet.
  • Good experience in the use of MS software.
  • Able to work effectively within a cross-functional teams inside and outside the organization.
  • Very good English communication and writing skills. The knowledge of French would be an asset.
  • Proactivity, autonomy, precision, good teamwork skills, excellent planning skills, meeting deadlines, good stress management, ability to cope with tight schedules
  • Analytical thinker with strong problem-solving skills.
  • Ability to resolve conflicts and develop a course of action leading to beneficial outcomes.
  • Strong communication skills, both oral and written.
  • 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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