Principle Scientific Associate Analytical Development & Quality Control
Start date:1/2/2021
Contract: 12 months with possibility of extension
Work location: Basel area
Job Responsibilities
- Organization of laboratory activities. Follow the processes defined in Guidelines and SOP's
- Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, cleaning verification/validation-, excipients-, content-, and potentially genotoxic impurity determinations
- Write-up of analytical methods for implementation
- Participation and collaboration in meetings at intra- and inter-departmental level (e.g., CMC)
- Conduct of release, retest, stability studies, transfer and validation analyses
- Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g. notebooks, raw data hardcopies)
- Review, interpretation and documentation of analytical protocols and reports, e.g. for validation and stability studies
- Assurance of adequate maintenance and operation of analytical equipment according to GMP
- Drafting and review of CoAs and/or Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs
- Organization of GMP-(re)qualification and validation of analytical equipment with external companies
- Elaboration of qualification plans and review of qualification documents
- Training of Laboratory personnel on advanced tasks and GMP regulations
- Ensuring of cleanliness of laboratory and workspace
- Independently designs and executes projects or experiments with hands on involvement
- Independently reviews scientific work in project related activities
- Ensures availability of adequate lab materials as well as justifies acquisition of new materials or equipment
- Contact for 3rd parties, e.g., CMOs and CROs for defined analytical tasks
- Independent evaluation and development of novel analytical techniques and instrumentation
- Leverages workload of respective project members to assure timelines and budget are met
- Review CMC sections for INDP/IMPD and NDA/MAA filings
- Design and perform laboratory work to support product or process troubleshooting, special investigations, CAPA and product complaints with minimal supervision
- Set and accomplish product development timelines working closely with formulation scientist
Candidate's Requirements
- Apprenticeship-, College-, or university-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemical engineering
- Apprenticeship 11+ years, BS 9+ years or MS 6+ years or PHD 0-2 years 'experience
- Ability to efficiently plan and effectively execute and document analytical experiments in a GMP-compliant pharmaceutical environment
- Good Knowledge of analytical chemistry with advanced knowledge of sample preparation, HPLC and spectroscopic instrumentation
- Good trouble-shooting skills for analytical analyses
- Good knowledge of GMP
- High flexibility, advanced communication, time-management and team-working skills
- Ability to work independently and to take initiative
- Life-long learning mindset and strong sense of accountability
- Should actively seek for technical solutions to improve quality and productivity
- Proficient in English
Candidates based in Switzerland or those with a valid Swiss work permit are preferred.
Randstad (Schweiz) AG
Region Basel