Project Scientist Dps Phys-chem Quality
vor 1 Woche
Key responsibilities:
- Review and approve GMP physchem analytical tests for assigned projects as required (specifically including HPLC, iCE and CE identity and purity methods, content by UV, identity, color, clarity and opalescence, pH, osmolality, extractable volume, CCI, visual inspection, subvisible particles and related DP analytics)
- Preparation and support of review of documents (including method validation, stability and other project related documents) as required
- Preparation of supporting documents required for lab testing
- Support lab team as first point of contact and monitor progress of sample testing and review
- Support Sample Management Team on logistics of project related samples incl. disposal
- Follow applicable SOPs and current GMP documentation practices.
- Support QC project leads in collection and compilation of project relevant documentation and assist in organization.
- Support the QC PL on successfully delivery of workpackages to support drug product development, in particular but not limited to method validation, release and stability testing of customer clinical programs under cGMP and all applicable regulations
Key requirements:
- Training on the job as lab technician (CTA, BTA, PTA or EFZ) incl. solid work experience in relevant area or BSc, MSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Solid working experience in Analytics or Quality Control, preferably under cGMP regulations is an advantage
- Working knowledge in all relevant analytical techniques and with laboratory specific software (e.g. Empower, Chromeleon, LIMSsystem)
- Experience in reporting, interpretation and documentation of scientific results
- Proactive attitude and attention to detail
- Ability to work independently and in a team
- Good communication and interpersonal skills
- Good knowledge of written and spoken English
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
Reference:
R51039:
- Apply
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