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Drug Product Technical Transfer Specialist/Formulation Specialist - (896930-SR)

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Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas is looking for a Technical Project Specialist for a 12 months contract based in Basel, Switzerland.

The ideal candidate should have at least 5 years of previous experience in product development and/or manufacturing of drug product and/or drug substance.

Drug Product Technical Transfer Specialist/Formulation Specialist - (896930-SR)

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas is looking for a Technical Project Specialist for a 12 months contract based in Basel, Switzerland.

The ideal candidate should have at least 5 years of previous experience in product development and/or manufacturing of drug product and/or drug substance.

Main Responsibilities:

  • Lead and manage development, analysis and production of drug substances and/or dosage forms, including clinical and market forms
  • Ensure sufficient and timely supplies
  • Identify need and opportunity for technology outsourcing.
  • Screen, evaluate and prioritize emerging technologies in terms of project needs, interest and values for the company’s ongoing and future projects
  • Identify and select partner companies for the activities necessary for the technical development and production
  • Negotiate general, financial and technical agreements with the contractors supported by internal partners
  • Support GQM to audit selected partners and to control cGMP status for clinical trial material and commercial products manufacturing
  • Plan, organize and administer the different aspects of the technical activities required for development, scale-up, validation and manufacturing of a drug from early development up to commercial supplies
  • Lead and manage all technical development and commercial manufacturing activities for assigned projects by developing and executing the overall CMC-project strategies
  • Lead and coordinate the Qbd/QRM process for assigned projects
  • Compile Technical Development Plan including the CMC-product strategy, and constructively challenge other functional plans. Ensure that overall project plan is considered in the CMC plan
  • Assess and plan costs and resource needs for the assigned project. Prepare and monitor project plans and budgets and negotiate them with Chemical or Pharmaceutical Development management and the Life Cycle team
  • Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level and to the project team(s)

Qualifications and Experience:

  • Pharmacist, Chemist or Equivalent with PhD (preferred) with minimum 5 years of relevant experience in the pharmaceutical industry e.g. in product development and/or manufacturing
  • Scientific expertise in the drug product or drug substance development and/or manufacturing
  • Ability to negotiate, plan, and coordinate technical development and manufacturing activities
  • Knowledge in QbD, DOE and QRM
  • Experience in the overall pharmaceutical development process over the whole product life cycle, from Phase 1 up to and including launch and beyond
  • Knowledge of GMP, quality control and pharmaceutical development and/or production processes based on current guidelines
  • Experience in setting development and regulatory strategies for products in development
  • Excellent English required (oral and written)
  • Relevant Swiss working/residency permit
 

Address

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

Website http://www.ctcresourcing.com

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