Physico-Chemical Laboratory Manager (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:
Physico-Chemical Laboratory Manager (f/m/d) 100%
The Physico-Chemical Laboratory Manager, 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 physico-chemical tests and analyzes of clean utilities, raw materials, semi-finished / finished products and stability samples according to the procedures and GMPs requirements. You will ensure the GMP level in the laboratory and be responsible for transfer and validation/verification of analytical methods and act as deputy of the Head QC.
- Bachelor or master’s degree in pharmacy, chemistry, biotechnology, life science or apprenticeship as chemical technician with a further education as certified technician HF
- At least 5-7 years professional experience in a regulated pharmaceutical quality control
- More than 7 years of professional experience in raw & packaging material regulatory
- Good understanding of QC laboratory processes and GMP requirements
- Sound scientific expertise in chemistry. Knowledge within analytical transfer, method validation/verification, for raw & packaging material, drug substances and drug products.
- Strong knowledge of analytical methods (water content, LC, GC, UV-Vis spectrophotometry, FTIR-spectrophotometry, dissolution …) and Pharmacopeias (EP, USP …)
- Strong knowledge of Validation/Verification & Transfer of analytical Method (Physico-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
- Self-dependent way of working and taking ownership of assigned tasks
- Proven leadership skills / lab organization
Role and Responsibilities:
- Responsible for performing various analytical physico-chemical testing according to internal and/or regulatory (EP, USP, other) standards for QC testing (water content, LC, GC, UV-Vis spectrophotometry, FTIR-spectrophotometry, Titration, conductivity, TOC, dissolution …)
- Ensure analysis deadline according to priorities (Organization and planning) and perform the required testing
- Deal with customers, contractor and manufacturing departments (ensure feasibility of the project)
- Ensure and performed sampling of raw material according to established procedures and regulatory requirements. Write and/or review sampling plan
- Ensure proper laboratory documentation associated with testing, OOS, Change Request, Deviation and CAPA in areas of assigned responsibilities according to established procedures and regulatory requirements
- Analyze, evaluate and interpret data; take a decision in issues, if applicable
- Ensure the qualification status of lab equipment and if necessary, participate to the qualification activities
- Ensure the implementation of new methods and equipment/instrumentation by performing required testing in support of development, transfer, validation/verification, qualifications, or suitability testing
- 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 Stability studies: write or review of stability protocols / reports. Perform the trend of stability study and provide a conclusion in areas of assigned responsibilities
- Review analysis performed in quality control laboratories in area of assigned responsibilities
- Write and ensure the trends of environmental controls and monitoring of clean utilities / rooms in area of assigned responsibilities
- 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
- Supports the Quality Control department in internal and external audits and requests
- Support QC colleagues in microbiological testing, after the respective training
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; firstname.lastname@example.org.
We are looking forward to welcome you in our new offices in the Stücki Business Center in Basel.