Expert manufacturing science analytical lab

Takeda (Neuchâtel NE, Schweiz) Vor 18 Tagen veröffentlicht
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An exciting and challenging opportunity has become available at the Takeda Neuchâtel Plant (approx. 620 employees) for a highly skilled analytical supervisor with validated experience in method transfer/method qualification for recombinant protein.

This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the manufacturing science team within a world-class Biotech manufacturing environment.

Job summary:

Manufacturing Science is owner of the process hence this team of SME’s (Subject Matter Experts) is a key player for all complex issues or projects involving the product. In the scope of the manufacturing science lab transformation a new analytical department will be created to support development projects, lifecycle projects and troubleshooting. The jobholder will have the following responsibilities:

During the project phase the jobholder will support the transfer of analytical method from Austria to Neuchatel. In addition, create SOPs, logbooks and all analytical documents needed to maintain high quality standard.

During routine phase the jobholder will have hand on experiments to ensure the daily testing of samples generated by the lab process team (cell culture and purification). She/he will be Responsible for training new colleagues, being identified as a method expert,

Essential Duties and Responsibilities:

  • Method transfer from Austria QC to Neuchatel MS lab
  • Method and lab equipment’s qualification
  • Trainer/Method expert
  • Manage stock of control/reagent
  • Collects, summarizes, and analyzes data to prepare reports and presentations, as appropriate.
  • Write and execute protocols to support process deviation
  • Presents the data to a scientific audience (R&D and Manufacturing science partners)
  • Lead investigation link to analytical methods
  • Evaluates and implements innovations in the area of expertise to deliver better performing solutions.
  • Perform routine testing
  • Project managment
  • Perform other duties as assigned

Education & Experience:

  • Master in biochemistry, biotechnology or equivalent
  • Minimum 5 years of experience in pharmaceutical industry, ideally as QC engineer
  • Strong knowledge of recombinant protein analytical methods (Activity, ELISA, SDS…)
  • Strong knowledges in method and equipment’s qualification
  • Strong experience in analytical method transfer
  • Good knowledge of quality system (trackwise, LIMS)
  • Analytical and problem-solving skills
  • Good statistical knowledges, green belt certification is a plus
  • Knowledge of GMP rules
  • Fluent in French and goof level of English (level C)

CHE - Neuchatel

Employee

Regular

Full time


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Expert manufacturing science analytical lab

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