Principal Scientific Associate

Swiss Franc45000 - Swiss Franc50000 per annum
  1. Permanent
  2. Biological Sciences
  3. Switzerland
Allschwil, Switzerland
Posting date: 17 Mar 2021
36368

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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