Quality Control Microbiology Manager
External Posting TitleQuality Control Microbiology ManagerJob DescriptionJOB OVERVIEW:
The main responsibility of the Quality Control (QC) Microbiology Manager is to lead activities associated with establishing the Environmental Monitoring and Utility Monitoring programs and to support the certification of Biogen’s new large scale manufacturing facility in Solothurn, Switzerland facility. The Microbiology manager will also be responsible for establishing the microbiology testing capabilities at the new drug substance production site, to include bioburden and endotoxin analyses of product and environmental samples, as well as identification capabilities. Microbiology will be responsible for water samples collected to support the WPU and WFI distribution loops as well as validation samples associated with cleaning studies. As such, the Microbiology manager should possess a strong understanding of total organic carbon and conductivity analyses. Familiarity with automated microbial testing procedures is desirable.
An initial strategy and timeline for facility certification has been established with support from global line functions within Biogen. The Microbiology manager will have the responsibility to operationalize the strategy and manage the timeline onsite at the new Solothurn facility. It will be critical that this position work cross-functionally with the Engineering, Validation and Quality Engineering teams to realize the facility certification against the timeline. The Microbiology manager is expected to possess expert level knowledge of regulations and guidance documents applicable to environmental, utility and water systems as well as the associated compendia based testing methods. As the facility is brought online, the microbiology manager will be responsible for managing the day to day operations of the Microbiology laboratory.
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 depends heavily 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, integrated sampling plans and multi-variant models are not requirements for the position, but would benefit the organization.
1. Support execution of the environmental, utility and facility certification strategy to bring the facility to operational readiness
2. 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
3. Drive activities at the Solothurn site to adhere to the construction or operational schedule
4. Support execution of analytical capability strategy. Work cross functionally to support purchasing, receipt, IQ/OQ/PQ of analytical equipment for the Solothurn site.
5. Oversee the early (pre-GMP) environmental and utility support activities (e.g. water system sampling). Support monitoring activities and data review as required. Oversee Supplemental staff supporting pre-GMP activities.
6. Serve as a Quality team member representative during construction to address schedule and tactical aspects of project execution.LocationSolothurn, SwitzerlandJob CategoryOperations, Technology & Innovation (PO&T)Requisition Number28302BRQualifications- Approximately 10 plus years of experience in pharmaceutical or biotech manufacturing environment. Prior experience within a GMP Quality Control function and at least 3 years of experience within personnel or project management experience is preferred.
- This position will require frequent international travel during the first two years of employment (up to 50% at times), periodically thereafter.
- English Fluent, German fluent strong preferred
- Prior experience with facility construction and start-up strongly preferred.
- Must have proficiencies with the Quality systems and business processes associated with analytical testing (drug substance and raw materials) and facility / utility operations.
- Demonstrated ability to work autonomously and to lead project teams without authority
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Strong presentation and organizational skills
- Ability to multi-task
- Demonstrated problem solving skills
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
- Candidates with experience in drug substance (or API) and drug product are preferred.EducationBachelor’s degree in Chemistry, Biology, Biochemistry or related Life Science or Technical disciplineAbout BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
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