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Pharmaceutical Development Project Manager




Kelly Scientific is exclusively mandated by STRAGEN Pharma SA Geneva to support the recruitment of a Pharmaceutical Development Project Manager.

8 months contract, 100%


YOUR...
Pharmaceutical Development Project Manager



Kelly Scientific is exclusively mandated by STRAGEN Pharma SA Geneva to support the recruitment of a Pharmaceutical Development Project Manager.

8 months contract, 100%


YOUR...



Kelly Scientific is exclusively mandated by STRAGEN Pharma SA Geneva to support the recruitment of a Pharmaceutical Development Project Manager.

8 months contract, 100%


YOUR MISSION:
The Pharmaceutical Development Project Manager is responsible for the Chemistry, manufacturing and Control (CMC) activities and life-cycle maintenance of Stragen products.


YOUR RESPONSIBILITIES:

Orphan drug / Biologic - Development follow up:
  • Supervise CMO for the further development and validation of manufacturing process (including viral clearance steps)
  • Supervise CROs for the validation of the viral clearance steps
  • Supervise analytical transfer activities (RP-HPLC, SEC-HPLC, SDS-PAGE, BCA assay, Enzymatic activity)
  • Complete development, characterisation and validation activities for the purpose of Phase II clinical study 
  • Follow-up of routine activities in place at CMOs
Biosimilars (In-Licensing) - Follow up:
  • Follow-up of routine activities for the purpose of WW registration
Orphan drug / Biologic , Biosimilars, New molecules development - CMC part:  
  • CMC (IMPD/IND) writing & Life Cycle Management according to current guidelines
  • Provide answers to technical questions from Health Agencies in duly time and in compliance with current regulations
  • Act as the contact point between the Pharmaceutical Development department in Geneva and the affiliates for the concerned projects  
  • Take part in regular team and technical meetings with affiliates 
  • Provide technical support in case of manufacturing or quality issues, closely link to Quality Assurance and Regulatory Affairs departments
  • Technical-regulatory intelligence 
Perform all other duties as assigned by the Management

 
 
EDUCATION & WORK EXPERIENCE
  • Pharm D. / University Degree in Pharmaceutical Sciences, Biochemistry, Biology, or related scientific field 
  • Industry specialization
  • Minimum 5 years of relevant experience working within pharmaceutical companies 
 
SKILLS
  • Extensive knowledge in proteins, peptides characterization and formulation
  • Knowledge in biosimilars as an asset
  • Knowledge in small molecules as an asset
  • Development, formulation and manufacturing skills
  • Pharmaceutical and chemical process manufacturing knowledge
  • Understanding of quality and regulatory issues (Drug substance and Drug Product)
  • Ability to keep informed about  technico-regulatory guidelines (ICH, Europe, America)
  • English communication skills, both in written and spoken
  • Adept in using MS Office tools (Excel, Word, PowerPoint, etc.)
  • Experience with a document submission management system (Docubridge...) as an asset

PERSONAL CORE COMPETENCIES
  • Able to build and maintain good customer / supplier / manufacturer relationship
  • Able to collaborate with a wide range of people
  • Time management skills
  • Decision making / ready to take initiatives 
  • Analytical skills 
  • Creativity in problem solving skills, logical, pragmatic 
  • Team player
  • Keen on working in an international environment within a growing company
  • Willingness to travel (about 20%)

If you think your profile fits to this position, don't hesitate to apply online on the Kelly Services website and it will be a pleasure for us to consider your interest.
 
Your contact at Kelly Scientific:
Karine LEGEROT
Consultant Professional Staffing Life Science

Adresse

Rue du Rhône 114 1204 Genève

Website http://www.kellyservices.ch