Principal Scientific Associate
A large biotech in Switzerland is in search for a Principal Scientific Associate to work in Analytical Development / Quality Control (AD/QC) to develop products that are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.
- Organisation of laboratory activities. Follow the processes defined in Guidelines and SOP's.
- Development, optimisation and implementation of analytical methods, and potentially genotoxic impurity determinations as well as write-up of these documents 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 data including results from method development, release, retest, validation, stability, and transfer.
- Write-up and review of analytical protocols, reports and specifications.
- Assurance of adequate maintenance and operation of analytical equipment according to GMP.
- Drafting and review of CoAs, Analytical results sheets, specification
- 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.
- Review CMC sections for IND/IMPD and NDNMAA filings.
- Design and perform laboratory work to support product or process troubleshooting, special investigations, CAPA and product complaints with minimal supervision.
Skills and Requirements
- University-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemical engineering with apprenticeship
- Ability to efficiently plan, 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 troubleshooting 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.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.