Microbiology Manager

Who we are:

Jubilant HollisterStier LLC, a well established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

What can we offer?

• A culture that values opportunity for professional growth and development while engaged in the manufacture of life-saving products
• Generous paid time off programs in addition to a generous paid holiday schedule
• Comprehensive medical, dental, vision, prescription and disability benefit programs starting day 1
• Company match for 401k and Roth, 100% vested from day 1
• Health and wellness programs, including Employee Assistance Program
• Education Assistance Program

Job Description:

The position of Manager - Microbiological Quality Control (MQC) is required to provide oversight and management of all functions associated with the quality control operations within the MQC laboratory, the Sterility test lab, and the general Safety Test facility, and to determine or recommend product disposition and corrective action measures when deviations occur related to microbiological specifications.

Provide guidance and direction to all departments within the Microbiological Quality Control unit, which includes the, microbiology lab, the sterility test lab, and the general safety test facility.

Ensure that all applicable U.S. and European regulatory requirements are being met within the procedures and practices of the MQC departments.

Review data summaries generated by the labs within the MQC unit, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted.

Provide necessary summaries and reviews for regulatory and customer inspectors/auditors; provide responses to written observations made by the inspector/auditors, and ensure that all corrective action measures are completed as described and within the time-frame given in the response.

Review and approve assigned Standard Operating Procedures (SOP's), Protocols and Acceptance Reports from the perspective of scientific soundness and compliance with applicable regulatory requirements, and provide input/changes as needed.

Ensure that investigations related to deviations (IURs, QAM's, and NCMR's) are complete and adequate to support his/her recommendation for product disposition and corrective action.

Prepare the annual expense budgets for the MQC departments, ensure that expense budgetary considerations are met, submit justifications for capital budget items as needed, and ensure that those approved items are ordered, received, and use implemented into use.

Review of Aseptic processes in the faciltiy.

Provide guidance to the facility in regards to aseptic processing and media fills.

Evaluate container closure systems and their suitability.

Qualifications:

• Bachelor of Science in Microbiology, Biology, or Biochemistry required. Master's degree desired.
• 5+ years of related experience required.
• Supervisory experience required. Managerial experience desired.
• Pharmaceutical experience, FDA regulated industry experience, laboratory experience, Quality Assurance experience all required.
• In-depth understanding of cGMP's, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.
• Experience with Microsoft Word, Excel, PowerPoint required.
• Physical requirements: Exposure to allergens, working in aseptic areas, prolonged sitting.

Jubilant HollisterStier is a great place to grow!

If you're up for a rewarding challenge, we invite you to take the first step and apply today!

http://www.jublhs.com/careers/employment-opportunities

*Please click on the Spokane, WA link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to their protected veteran status and will not be discriminated against on the basis of disability.

If you require assistance applying for a position, please contact our HR Department at:

HResources@jhs.jubl.com