Laboratory Manager / Leader (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 organisation (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:
Laboratory Manager / Leader (f/m/d) 100%
The Lab Manager / Leader, 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. He/she will ensure the GMP level in the laboratory and be responsible for transfer and validation of analytical methods and act as deputy of the Head QC.
- Bachelor or Master degree in pharmacy, microbiology, biotechnology, life science
- Extensive experience in a regulated pharmaceutical quality control and analytical development
- Good understanding of QC laboratory processes and GMP requirements
- 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 (Characterization, Assay (CFU, LC), purity, dissolution, water content …) and Pharmacopeias (EP, USP …)
- Strong knowledge of Validation & Transfer of analytical Method (microbiological and Physic-Chemical 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
Role and Responsibilities:
- 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 (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 according established procedures and regulatory requirements
- Ensure the qualification status of lab equipment and if necessary, participate to the qualification activities
- Write and ensure 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, R & D…)
- 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
- 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 activities
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.