QC Laboratory Manager / Leader Microbiology

QC Laborator Manager / Leader Microbiology (f/m/d) 100%. Visp, CH

Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

Create your own future as:

QC Laboratory Manager / Leader Microbiology (f/m/d) 100%

 The QC Lab Manager / Leader, a member of the Quality Control, plays an essential role in the daily analytical operations to support the manufacturing of LPBs. He/she
ensures the execution of microbiological tests and analyzes of clean utilities, raw materials, semi-finished / finished products, and stability samples according to the procedures and GMPs requirements.  He/she will ensure the GMP level in the laboratory and be responsible for transfer and validation of analytical methods. He/she will report to the QC Team Lead and act as deputy of him.

My main tasks will be…

  • Ensure analysis deadline according to priorities (Organization and planning)
  • Deal with customers and contractor (ensure feasibility of the project)
  • Ensure proper laboratory documentation associated with testing and investigations in areas of assigned responsibility according to established procedures and regulatory requirements
  • Analyze, evaluate and interpret data; take a decision in issues, if applicable
  • Write and/or review quality documentation as SOPs, Equipment qualification documents (QPP, URS, RA, IQ/OQ/PQ, QP), Method Transfer & Validation/Verification (Validation/Transfer protocol and report)
  • Ensure the implementation of new methods and equipment/instrumentation by performing required testing in support of development, transfer, validations, qualifications, or suitability testing
  • Ensure Stability studies: write or review of stability protocols / reports. Perform the trend of stability study and provide a conclusion
  • Review analysis performed in quality control laboratories or externally which are under the responsibility of quality control
  • Investigates and documents errors, out-of-specification analyses, deviations and change request according to established procedures and regulatory requirements
  • Ensure the qualification status of lab equipment and if necessary, participate to the qualification activities
  • Responsible for the trends of environmental controls and monitoring of clean utilities / rooms
  • Support QC colleagues in case of issues
  • Advise employees on technical issues (Production, Quality Assurance…)
  • Ensure the function of the LIMS: creation of working-sheets, specifications, methods. Ensure the sample entry. Ensure equipment management
  • 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

I bring with me…

  • Bachelor or master’s degree in pharmacy, microbiology, biotechnology, life science
  • More than 10 years of experience in a regulated pharmaceutical quality control and analytical development
  • Good background of QC laboratory processes and GMP requirements in clinical phase and commercial, is an asset
  • Sound scientific expertise in microbiology, preferable bacteriology. Knowledge within analytical transfer, method validation, method development for drug substances and drug products. Experience to work with isolator.
  • Knowledge with Probiotics is an advantage
  • Strong knowledge of analytical methods (Identification, purity, enumeration …) and Pharmacopeias (EP, USP …)
  • Strong knowledge of Validation/Verification & Transfer of analytical Method (microbiological methods)
  • Good knowledge of instrument / equipment qualification
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment
  • Very good communication and negotiation skills in German & English
  • Structured, focused, and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
  • Proven leadership skills / lab organization

My reasons for choosing Bacthera…

  • Innovative and fast-growing start-up company with short decision-making processes
  • Flexible working hours (possibility of Home Office)
  • Motivated, agile and multinational team
  •  Very good pension fund and attractive salary
  • Fringe benefits (e.g. Lunch card, deduction at different stores, Job ticket for public transport)
  • Interesting and diversified tasks

This is the opportunity to be part of a fast growing start-up company, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting to you, we are looking forward to hear more about you.

Please send all your documents (motivation letter, CV, letter of references, diplomas, etc.) to Ms. Sandra Gamboni, Global Head of HR. HR@bacthera.com

I am looking forward to your application!

Sandra Gamboni
Global Head of HR