Contract Scientific Associate Analytical Development and Quality Control

3 days left

Location
Basel
Salary
Market Rate
Posted
19 Aug 2019
Closes
18 Sep 2019
Ref
MJPSwitz2
Discipline
Quality, GLP, GMP, QA / QC, QC Analyst
Hours
Full Time
Contract Type
Contract
Experience Level
Management

Michael Parker at Umbilical -Life is recruiting an initial 12-month contract Scientific Associate Analytical Development and Quality Control to be based in Basel, Switzerland. This client is a well known and rapidly growing pharmaceutical company that has a range of both clinical and commercial products.

You will be responsible for performing lab activities related to CMC projects in terms of the development of analytical methodology and characterisation of sterile drug products.

Role Responsibilities:

  • Organization and execution of lab work for parenteral drug products.
  • Implementation of new analytical techniques required for parenteral drug products
  • Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, content and potentially genotoxic impurity determinations
  • Conduct of release and stability tests under cGMP and non-GMP
  • Planning and execution of method transfers and validations including respective documentation
  • Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability and transfer
  • Assurance of adequate maintenance and operation of analytical equipment according to GMP

Qualifications:

  • Apprenticeship, college-, or university-degree or equivalent education in the field of chemistry, biochemistry, biology, pharmacy, or chemical engineering. A minimum of 4 years of work experience in the analysis and method development for parenteral drug products.
  • Skilled in the application of cGLP/cGMP.
  • Extensive analytical development background and hands-on lab experience of analytics for sterile drug products.
  • Experience in late phase development activities, e.g. analysis of drug product supplies for pivotal clinical trials, registration stability studies and process validation
  • Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
  • Prior experience with complex parenteral products and medical devices.
  • Expertise in the development and validation of analytical methods used for the characterization and control of parenteral products.
  • Excellent interpersonal/ organizational skills and the ability to multi-task. Strong oral/ written communication skills, proficiency in English. German/French is a plus
  • Computer literacy (e.g. Waters Empower, ELN).

For more information on this role or others I am recruiting please don’t hesitate to get in touch.

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