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Job type: Permanent

Discipline: Biological Sciences

Location: Switzerland

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.

Job Responsibilities

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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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