Die besten 21’272 Jobs in der Region.

13.01.2021

Senior Manager QC, Microbiology

  • 4542Luterbach
  • Vollzeitstelle

Originalinserat öffnen

Senior Manager QC, Microbiology

Job Description

  • The QC Microbiology Sr. Manager will be responsible for managing the microbiology testing capabilities for a large scale manufacturing site in Solothurn, Switzerland, Responsibilities include managing a QC Microbiology department in support of bioburden and endotoxin analyses of product and environmental samples, as well as identification capabilities.  Microbiology is responsible for analyzing 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.
  • The Sr. Manager will be responsible for working cross-functionally with the Engineering, Validation and Quality Engineering teams to support the site in GMP licensure.  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.  The Microbiology manager will be responsible for managing the day to day operations of the Microbiology laboratory.
  • In addition, the Sr. Manager QC Microbiology will be responsible for
    • Providing Quality input in Facility Engineering related activities
    • Providing Quality input into QC Analytical equipment setup and operability
    • Resolving routine compliance  issues impacting site operations while keeping Quality management informed
    • Approving routine site related Analytical procedures without need for elevation
    • Providing input into regulatory documentation (i.e. filings, APRs etc.) while keeping Quality management informed

Qualifications

  • Bachelor’s degree in Chemistry, Biology, Biochemistry or related Life Science or Technical discipline
  • 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
  • Proven experience in leading teams and managing direct reports
  • Dual Language preferred with a preferences for German and English
  • Prior experience with facility start-up strongly preferred
  • Must have proficiencies with the Quality systems and business processes associated with Microbiology testing (drug substance and Environmental) as well as 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
  • Knowledge of Virology and viral safety testing of Biologics is not a requirement for the position but would benefit the organization

Additional Information

  • The Quality Control organization at the Solothurn site is 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 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.
  • Position will work with all levels across multiple areas within the organization to lead/complete routine Quality activities (analytical data / model review and interpretation, review of maintenance related activities, etc.)
  • Position will work with all levels across multiple areas within the organization (within and across sites) to ensure compliance to applicable regulatory guidelines
  • Position will work with all levels across multiple areas within the organization (within and across sites) to help establish, implement and refine Analytical related systems

Arbeitsort:

4542Luterbach