Microbiology Manager & Environmental Monitoring
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica’s mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country’s most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.
With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023. As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunity to progress YOUR career.
The Microbiology Manager & Environmental Monitoring for Civica's Petersburg, Virginia location just outside of Richmond includes the following essential responsibilities:
The Microbiology & Environmental Monitoring Manager will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s 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.
Essential Duties and Responsibilities
- Working across functions, lead the Environmental Monitoring (EM) program and microbiology testing Laboratory to enable the reliable supply of Civica 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.
Minimum 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.
Salary DOE, Excellent Benefits
You must be eligible to work in the US to be considered an applicant.