Req ID
Pharmaceutical Development Project Manager
Title
Pharmaceutical Development Project Manager
City
6850 Mendrisio
State/Province
Canton Ticino
Country
Switzerland

Company Overview
Established in 1921 in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide, through innovative science and excellence in development, production and marketing. Our people are the biggest asset. That is why we believe in the great place to work culture that promotes creativity, informed risk-taking, an exciting environment and a good feeling in every day work. To strengthen our Pharmaceutical Development team at our headquarter in Mendrisio (Switzerland), we are currently looking for a Pharmaceutical Development Project Manager (fulltime position).

Responsabilities
  • Coordination and support of the activities related to the assigned project
  • Collaboration with internal departments to reach the project goal
  • Preparation and maintenance of product eCTD CMC Part (Module 3 and 2.3) with a focus on Swiss, European and US guidelines. Other international markets, such as MENA regions and Far East regions could also be part of the professional focus
  • Identification and interpretation of regulations and guidelines issued by applicable regulatory agencies and other regulatory organizations
  • Improve pharmaceutical development knowhow and related EU/US/Global regulations intelligence by attending courses, seminars and meetings
  • Other duties as directed

Position Description
The Pharmaceutical Development Project Manager will manage projects related to both new drug products and
optimization of processes, presentations and formulations related to drug products already in place.

He/She will operate under the direct coordination of the Pharmaceutical Development Corporate Manager and in collaboration with colleagues working within the Pharmaceutical Development team and within the Scientific Affairs Department which the Pharmaceutical Development is part of.
He/She will follow the project starting from the “idea” until the formalization of the results in the CMC part (Module 3 and 2.3) of the related eCTD.

Qualification and Skills
  • Bachelor’s degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry)
  • + 2-3 years’experience in research and development project management
  • Knowledge of ICH/EU/US/Swiss guidelines related to the technical subjects as manufacturing equipment and process validation, stability and photostability studies, elemental impurities, extractable & leachable, analytical methods validation
  • Experience in eCTD CMC Part (Module 3 and 2.3) compilation and management would be an asset
  • The knowledge of EU/US/Swiss regulations related to the eCTD CMC Part (Module 3 and 2.3) compilation and modification would be an asset
  • Good expertise in the use of MS software
  • Good English communication and writing skills.
    The knowledge of French will be considered an asset   
  • Able to work independently and complete assigned tasks within established deadlines
  • Able to work within the team
  • Strong attention to details
  • Analytical thinker with strong problem-solving skills
  • Commitment to continuous improvement
 
We offer
A fulltime permanent employment within a young and positive working environment.
 
Additional information and contacts
Applications can be submitted electronically via this official online form.

HR and Corporate Sustainability Department
+41 (0)91 640 42 50
hr@sintetica.comwww.sintetica.com
Removal Date
11-Oct-2017
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