QC Lab Technician, Pharmaceutical

Live Biotherapeutic Products (f/m/d) 100%

For our site in Basel we are seeking (starting June 2020) a motivated, out of the box thinking person:

The QC Lab Technician, a member of the Quality Control, plays an essential role in the daily analytical operations to support the clinical manufacturing of LPBs. He/she ensures the execution of microbiological and physic-chemical tests and analyzes of clean utilities, raw materials, semi-finished / finished products and stability samples according to the procedures and GMPs requirements.

Your profile

  • You have a profound knowledge in QC as Lab. Technician or an Academic university degree in pharmacy, microbiology, biotechnology, life science with at least 6 years of professional experience
  • At least 3 years relevant experience in a regulated pharmaceutical quality control
  • Good understanding of QC laboratory processes and GMP requirements
  • Sound scientific expertise in microbiology, preferable bacteriology. Knowledge within analytical tech transfer, method validation, method development for drug products and microbiology. Experience to work with isolator is an asset
  • Knowledge with Probiotics is an advantage
  • General knowledge of analytical methods (Assay, purity, dissolution, water content …) and Pharmacopeias (EP, USP …)
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment
  • Very good communication and negotiation in German & English (verbal and written)
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
  • Excellent interpersonal, communication and team collaboration skills
  • Excellent verbal, written and interpersonal communication skills. Reads, write and speaks English and German
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
  • Solution oriented and collaborative quality mindset, Strong fact-based decision maker

Role and responsibilities

  • Conducts routine microbiological and physic-chemical analyses of clean utility, drug substance, raw material, drug product, and environmental monitoring samples in compliance with established procedures and regulatory requirements
  • Contribute to ensuring analysis deadline according to priorities (Organization and planning)
  • Must be capable of maintaining laboratory documentation associated with testing and investigations in areas of assigned responsibility according established procedures and regulatory requirements
  • Must analyze, evaluate, and interpret data, and assisting to resolve issues, if applicable
  • Reviews the analyzes, in the area of his skills
  • Participate in the writing and ensure the trends of environmental controls and monitoring of clean utilities
  • Maintains a level of technical knowledge and understanding in the assigned area of responsibility, including use of equipment and instrumentation and is able to troubleshoot problems, if they occur
  • Supports the implementation of new methods and equipment/instrumentation by performing required testing in support of development, transfer, validations, qualifications, or suitability testing
  • Advise employees on technical issues (Production, Quality Assurance, R&D)
  • Must update and write new procedures, methods, protocols, and reports, as requested

Are you interested to work for an innovative, dynamic and future oriented start-up company? If you are looking for a new challenging role were you can create things and leave your footprint then send us your full application to Ms. Sandra Gamboni, Head of Human Resources; saga@bacthera.com

We are looking forward to welcome you in our new offices in the Stücki Business Center in Basel.