QC Laboratory Technician (f/m/d) 100%, Basel CH
We combine best-in-class capabilities from our two founding partners, including extensive know-how in developing, upscaling and manufacturing live bacteria, strong capabilities in pharma contract manufacturing, and outstanding formulation and drug delivery technologies, including the unique enTRinsic™ capsules.
Bacthera operates from its headquarters in Basel (CH) and has development and production facilities in Denmark and Switzerland. Bacthera is the first contract development and manufacturing organization (CDMO) to provide a full supply chain that offers manufacturing of live bacteria for therapeutic use for biotech and pharma customers.
For our site in Basel we are seeking a motivated, open minded and experienced person as:
QC Laboratory Technician (f/m/d) 100%
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.
- You have a profound knowledge in QC as Laboratory Technician or an Academic degree in pharmacy, microbiology, biotechnology, life science with at least 5 years of professional experience
- At least 5 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 microbiological analytical tech transfer, method validation, method development for drug substances and drug products
- Knowledge within equipment qualification
- Experience to work with isolator and knowledge with Probiotics are 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
- 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
- Ensure 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? Are you looking for a new challenging role where you can create things and leave your footprint? If you can answer those questions with YES, then send us your full application to Ms. Sandra Gamboni, Head of Human Resources; email@example.com.
We are looking forward to welcome you in our new offices in the Stücki Business Center in Basel.