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QC Manager, Microbiology

Employer
Tonix Pharmaceuticals
Location
North Dartmouth, Massachusetts, US
Salary
Competitive
Closing date
May 30, 2022

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
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Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

The Manager, Quality Control Microbiology will oversee the microbiology function in support of QC raw material, drug substance and finished product testing for products produced at the Tonix manufacturing facility and affiliated contract organizations. In addition to routine testing, this role will oversee the environmental monitoring program, implementation of general laboratory operational systems and microbiological testing capabilities, related method transfer and qualification activities, investigations, and assay/instrument troubleshooting. Also, the individual will be supporting the buildout of the QC laboratories of a site specific GMP manufacturing facility in Dartmouth, MA opening in 2022. The individual in this position will have the unique opportunity to hire, train and oversee performance management, mentoring and career development.

This position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate. Also, this role will also provide support for the appropriate QC strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance.

This position reports into the Associate Director of Quality Control and is a member of the Quality management team at the facility. The role will be based out of the new facility in Dartmouth, MA once open and operational. Remote work arrangements will be in place until such time.

Essential Duties:
  • Oversee day-to-day operations of the Quality Control Microbiology function
  • Manage laboratory personnel and oversee their selection, performance management, mentoring, and career development
  • Direct the implementation of in-house testing capabilities in the QC laboratory, including bioburden, endotoxin, and sterility assays as well as microbial identifications as required
  • Develop and maintain the environmental monitoring program
  • Support routine testing for raw materials, drug substance and drug product internally and at CMOs and contract laboratories
  • Provide testing data and other required quality-related information needed to support clinical studies
  • Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Troubleshoot issues related to laboratory procedures and assay performance
  • Manage laboratory investigations, change controls, and CAPAs for relevant QC operations
  • Provide support to audit teams for internal and vendor audits
  • Contribute to departmental budget and resource allocation
  • Prepare and monitor metrics to ensure control of systems and drive continuous improvements
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Utilize data to risk assess recoveries in support of manufacturing
  • Execute special projects as necessary to support various business initiatives

Minimum Qualifications:
  • Bachelor's degree in Microbiology or a relevant scientific discipline preferred
  • Eight (8) years of cGMP QC experience in biotechnology/large molecule industry strongly preferred
  • Prior experience in Quality leadership in the pharmaceutical/biotechnology industries
  • Strong understanding of QC principles, USP/Ph Eur compendia testing requirements and various microbiological testing techniques
  • Experience in method transfer and qualification/validation activities
  • Experience with risk assessment
  • Demonstrated troubleshooting and problem-solving skills
  • Excellent written, and verbal communication skills
  • Dedicated team player who is able to withstand the high demands of a fast-paced environment
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, collaborator
  • Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.
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