- Support the preparation of the Microbiology lab and WIP lab for routine operations and support the execution of analytical capability strategy. Work cross functionally to support purchasing, receipt, IQ/OQ/PQ of analytical equipment for the Solothurn site.
- Support the environmental and utility monitoring program for the site. Support day to day analytical operations within the Central and WIP labs.
- Author and review complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations, etc.
- Work cross functionally to support purchasing, receipt, IQ/OQ/PQ of analytical equipment for the Solothurn site.
- Perform all analytical activities for equipment qualification and validation of microbiological methods and subsequent routine operations
- Apprenticeship degree (Laborant EFZ) in Biology or related Life Science or Technical discipline.
- Strong experience within Biological Quality Control, Microbiology and analytical function. Approximately 4 plus years of experience in pharmaceutical or biotech manufacturing environment.
- Strong analytical skills in Microbiology
- Must have a working understanding of modern analytical microbiological modalities to facilitate the execution of analytical quality strategies
- Demonstrated problem solving skills
- Demonstrated ability to work autonomously and cross-functionally
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Ability to multi-task and to work under pressure
- Strong presentation and organizational skills
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Power Point, Visio, etc.)
- Must have proficiencies with the Quality systems and business processes associated with Microbiology testing (drug substance)
The main responsibilities for the Quality Analytical Associate III Microbiology includes execution of all of the Microbiology related testing activities at Biogen’s new large scale manufacturing facility in Solothurn, Switzerland. The Quality Analytical Associate III will also be accountable to support IQ / OQ / PQ of instrumentation and method validation in alignment with Biogen and Industry standards. Microbiology related analysis at the site will include: microbiological identification, bacterial endotoxin test (kinetic-chromogenic), detection of microorganisms (BacT/Alert) and microbial enumeration test. Additional tests will include Total Organic Carbon and conductivity. In addition, the Quality Analytical Associate will contribute to the development and execution of QC Microbiology related supporting studies.
Work in-progress (WIP) laboratories are embedded into, or adjacent to, the manufacturing workspace at Biogen’s new facility. All operations at the facility are focused on batch production and release of the drug substance materials produced at the site. The Quality Analytical Associate III has to support all activities to ensure that the instrumentation in these WIP labs is prepared for each corresponding unit operation to be performed in manufacturing. The Quality Analytical Associate III also supports training of the On-The Floor (OTF) Quality staff members and Manufacturing Associates that will perform routine test execution. While the OTF staff and Manufacturing Associates has accountability for routine test execution, trouble shooting of analytical or assay related issues is supported by the Quality Analytical Associate III. Analytical methods or techniques requiring segregation from the manufacturing areas will be maintained in a central laboratory adjacent to the manufacturing buildings. Techniques to be performed in the central laboratory will include growth promotion test, microbial enumeration of in-process and EM/UM samples, Bacterial Endotoxin Test (kinetic-chromogenic) and microbiological identification.
The Quality Analytical Associate III has a strong background in microbiological analytical methodologies. The Quality Analytical Associate III is expected to become a subject matter expert for classical and rapid methods and its instrumentation in support of the QC Microbiology Scientist. The Associate has to correctly work with cGMP regulated computerized systems which are necessary for the testing workflow as these systems will support the vision of establishing a paper-less lab and ensure the relevant data integrity. The Quality Analytical Associate III supports the Microbiology Team with establishing analytical procedures and protocols related to microbiological analysis.
The Quality organization at the new Solothurn site is envisioned to be supported by team members with diverse backgrounds that are capable of cross functional work to support the high throughput design of the facility. As the site moves through the design phase into operational readiness, Quality staff is focused on incorporating a new operations strategy into the quality management systems, lab systems and business systems. The operational strategy strongly relies on the incorporation of online real-time monitoring, automation of routine testing wherever possible and integrated information technology systems to bring transparency to routine business operations.