Manager, Microbiology - Pharmaceutical

Grimaldi Staffing Services
Petersburg City, Virginia, US
Jul 01, 2021
Aug 18, 2021
Employment Type
Full time
Salary Type

The Microbiology Manager bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance at company new Petersburg Virginia site.. The Petersburg site serves as new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. Responsibilities of the position include establishing and maintaining the environmental control program and microbiology testing laboratory from onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

The role is essential to assure the Petersburg site's environmental control systems and microbiology testing complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices, and FDA Guidance documents) and expectations for the development and reliable supply of quality medicines. Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to support the design, implementation, and maintenance of a robust environmental control system and microbiology laboratory that meets or exceeds FDA requirements. This position will hire and then manage Lab Associate level employees and perhaps others as the team grows. Position will be in Petersburg Virginia and will report to Site Head of Quality and Compliance.

  • Working across functions, lead the Environmental Monitoring (EM) program and microbiology testing Laboratory to enable the reliable supply of generic medications to patients.
  • Build and lead a high performing site Microbiology team.
  • Participate or lead EM/microbiology related quality systems activities including, but not limited to, aseptic process simulations (i.e., media fills) and environmental monitoring risk assessments and control plans, facility, utility, and isolator filling line qualifications, change control, CAPA, deviations and investigations.
  • Develop and/or improve environmental control processes and systems.
  • Identify, track and facilitate resolution of technical issues.
  • Track, trend, and analyze EM and microbiology testing data for the site. Recommend action and continuous improvement plans. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Council meetings.
  • Participate or lead the assessment, qualification, and approval of suppliers.
  • Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
  • Lead and maintain aseptic training program and sterility assurance risk assessments.
  • Author and/or review and approve SOPs, protocols, reports and test method documents as applicable.
  • Promote a quality mindset and quality excellence approach to all activities.
  • Travel (up to 10%) may be required.

Basic Qualifications and Capabilities:
  • Bachelor's degree in a scientific discipline (microbiology degree preferred) with a minimum of 8 years Quality/CGMP management experience in the pharmaceutical industry. Experience in sterile injectable manufacturing, aseptic processing and facility qualification.
  • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
  • Microbiology testing and environmental monitoring management experience across the product development and commercialization lifecycle including facility and utility qualification and ongoing monitoring in assuring a state of microbiological control.
  • Participation and leading activities to support regulatory agency inspections required.
  • Minimum of 2 years' experience in a supervisory role highly desired.
  • Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
  • Ability to work autonomously and within established guidelines, procedures, and practices.
  • Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills and share knowledge with others.

Preferred Qualifications:
  • Technical expertise in pharmaceutical and combination product process and isolator technology highly desirable.

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