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CHCH12 Lonza AG

Senior GMP Validation Scientist – Laboratory Execution Physico-Chemical Quality Control(m/w/x)

Basel
Full-timeOn-siteSenior

Hands-on validation of physico-chemical analytical methods for biologics, setting up labs and managing CDS Empower at a life sciences firm. Proven track record in GMP regulated QC lab, expert CDS Empower experience highly advantageous. Direct impact on new lab execution for biologics.

Requirements

  • BSc/MSc in analytical chemistry, biochemistry, or related field or training as a lab technician
  • Extensive working experience in a research/technical role in the pharmaceutical or chemical industry
  • Proven track record in applying analytical methods in a QC or GMP regulated laboratory
  • Advanced scientific knowledge of physico-chemical analytical methods
  • Expert experience with laboratory specific software (e.g. CDS Empower) is highly advantageous
  • Advanced knowledge in comprehensive reporting, interpretation, and documentation of scientific results
  • Good communication and interpersonal skills, ability to work independently in a team
  • Good knowledge of English (written and spoken), German is a plus

Tasks

  • Perform hands-on laboratory work with a variety of analytical test methods for biologics
  • Evaluate new analytical test methods during pre-validation activities
  • Set up the laboratory for first execution, including ordering materials and creating CDS Empower files
  • Plan, execute, and evaluate validation experiments according to protocols, SOPs, and Good Documentation Practices
  • Manage CDS Empower folders and methods as a Power User
  • Maintain a clean laboratory environment to cGMP standards for audit readiness
  • Ensure compliance and up-to-date training for required tasks
  • Assist in investigations and troubleshooting by proposing mitigation measures
  • Initiate and participate in improvement initiatives at the LEAN white belt level

Work Experience

  • approx. 4 - 6 years

Education

  • Vocational certificationOR
  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic

Tools & Technologies

  • CDS Empower

Benefits

Bonuses & Incentives

  • Compensation programs that recognize high performance

Career Advancement

  • Agile career

Informal Culture

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace
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