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LOLonza

Analytical Project lead Commercial QC(m/w/x)

Basel
Full-timeOn-siteSenior

Leading commercial QC projects for biotechnology products, authoring GMP documents and managing LIMS. MSc in Analytical Chemistry or related field with cGMP experience required. Agile career path, high-performance recognition programs.

Requirements

  • MSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
  • Experience in Analytics or Quality Control under cGMP regulations
  • Proven project management success
  • Knowledge of regulatory requirements and analytical lifecycle for biotechnology products and CMC requirements
  • Strong communication and interpersonal skills with proactive attitude
  • Detail-oriented and ability to work in matrix organization
  • Business fluent English, written and spoken
  • Excellent written and verbal communication skills in English

Tasks

  • Lead and manage pharmaceutical projects in commercial QC
  • Author and review complex GMP and project documents
  • Ensure timely delivery of QC work packages
  • Close out and authorize documents and reports
  • Manage LIMS specifications and change requests
  • Address risks and resolve issues proactively
  • Complete sample lifecycle from sampling to disposal
  • Collaborate with Lab Support and Sample Management Teams
  • Act as single point of contact for assigned projects
  • Represent commercial QC in internal and customer meetings
  • Network with partner units and stakeholders
  • Review and approve assay documentation
  • Maintain knowledge of analytical method capabilities
  • Support definition of Critical Quality Attributes
  • Develop analytical control strategy

Work Experience

  • approx. 4 - 6 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Benefits

Bonuses & Incentives

  • Compensation programs recognizing high performance

Career Advancement

  • Agile career

Informal Culture

  • Dynamic work culture

Purpose-Driven Work

  • Inclusive and ethical workplace
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