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
The QC Lab Technician, 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 physico-chemical 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 Lab Manager.
My main tasks will be…
- Conduct routine physico-chemical analyses (Identification, water content, water activity, disintegration, FTIR, UV-VIS..) on release and stability samples and evaluate/interpret data
- Ensure analysis deadline according to priorities (Organization and planning)
- Ensure proper laboratory documentation associated with testing and investigations in areas of assigned responsibility according to established procedures and regulatory requirements
- 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)
- Support 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: authoringstability protocols / reports.
- 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
- Support QC colleagues in case of issues
- Advise employees on technical issues (Production, Quality Assurance…)
- Is responsible for sample management (LIMS)
- 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
- Ensures all aspects of the laboratory, including but not limited to the instruments / equipment, and the supplies necessary to ensure the proper functioning of the laboratory according to the pharmaceutical Quality Management System (QMS) and the respective health authority regulations. Provide new analytical technologies in respect of our activitie
- Support the QC Lab manager by managing raw & packaging materials, consumables and single use materials (Review of Raw Material Risk Assessment, need of CRO, Shipment, assists to customers’ meetings, if required)
- Ensure the implementation and/or update of GMP documents regarding Raw & Packaging Materials
- Support handling of quality events (Deviation, CAPA, Change Request, …)
- Ensure laboratory security (HSE, Biosafety) and ensure that the laboratory remains in compliance with all internal, national, federal, and regulatory procedures
- Participates to regulatory inspections and client audits
- Ensure the archiving of quality control documents (analytical file, logbooks, CoAs, validation / transfer protocols and reports ...)
I bring with me…
- Bachelor or master’s degree in pharmacy, microbiology, biotechnology, life science
- More than 3 years of experience in a regulated pharmaceutical quality control lab or analytical development or more than 5 years of experience in quality control in a chemical or a food industry
- Strong knowledge of analytical methods (Identification, , Disintegration, Water Content, Container Closure System …) and Pharmacopeias (EP, USP …)
- Knowledge of QC laboratory processes and GMP requirements in clinical phase and commercial, is an asset
- Sound scientific expertise in physico-chemical analysis.
- Profound knowledge managing, sampling and testing of raw materials
- Knowledge with Oral Dosage Form is an advantage
- Strong knowledge of Validation/Verification & Transfer of analytical Method
- 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
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