The main responsibilities for the Quality Control Sr. Associate I Microbiology will include execution of all of the Microbiology related testing activities at Biogen’s new large scale manufacturing facility in Solothurn, Switzerland. The Quality Control Sr. Associate will also be accountable to support the proper IQ / OQ / PQ of instrumentation and method validation in alignment with Biogen and Industry standards in collaboration with the Aanlytical Scientist. 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. Automated/rapid as well as traditional methods will be applied. As the facility is being finalized for drug substance production, the Quality Control Sr Associate will support the facility certification with respect to the environmental monitoring (EM) and utility monitoring (UM).
Work in-progress (WIP) laboratories will be embedded into, or adjacent to, the manufacturing workspace at Biogen’s new facility. All operations at the facility will be focused on batch production and release of the drug substance materials produced at the site. The Quality Control Sr Associate 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 Control Sr Associate will also be accountable to support training of the On-The Floor (OTF) Quality staff members that will perform routine test execution. While the OTF staff will have accountability for routine test execution, trouble shooting of analytical or assay related issues will be supported by the Quality Control Sr Associate. 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 Control Sr Associate should have a strong background in microbiological analytical methodologies. The Quality Control Sr Associate is expected to become a technical expert for classical and rapid methods and its instrumentation. 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 Control Sr Associate will support the Microbiology Team with establishing analytical procedures and protocols related to microbiological analysis. The Quality Control Sr Associate will strongly support all compliance aspect related to analytical testing and will support investigations and root cause 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 will be 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. As such, experience with electronic batch records and integrated sampling plans would be of advantage.
Accountability Description:
1. 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.
2. Perform all analytical activities for equipment qualification and validation of microbiological methods and subsequent routine operations
3. Support the facility certification and establishment of the environmental and utility monitoring program for the site. Support day to day operations within the Central and WIP labs.
4. Author, review and approve complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations, etc.) requiring the ability to grasp and apply regulatory and compliance knowledge from multiple markets/agencies
Strong experience within Biological Quality Control, Microbiology and analytical function. Approximately 8 plus years of experience in pharmaceutical or biotech manufacturing environment.
Must have proficiencies with the Quality systems and business processes associated with Microbiology testing (drug substance)
Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Power Point, Visio, etc.)
Strong analytical skills in Microbiology and compliance aspects
The main responsibilities for the Quality Control Sr. Associate I Microbiology will include execution of all of the Microbiology related testing activities at Biogen’s new large scale manufacturing facility in Solothurn, Switzerland