Beschreibung

In this role, you will engage in hands-on laboratory work, evaluating and validating analytical test methods while ensuring compliance with cGMP standards. Your daily responsibilities will include planning experiments, maintaining laboratory readiness, and driving improvement initiatives.

Anforderungen

• •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

Aufgaben

• •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

Tools & Technologien

Benefits