Job Information
Actalent QC Microbiology Manager in Alachua, Florida
Job Description:
Manage Quality Control Microbiology staff including recruiting, onboarding, and performance management.
Implement a program to mentor, coach, train, and identify talent (external/internal) for importation into the program.
Focus on employee engagement by creating a culture of transparent communication, teamwork, and empowerment with a strong focus on career development for Quality Control Microbiology staff.
Develop short-term and long-term goals for Quality Control Microbiology team in alignment with project goals and broader organizational goals; monitor progress against goals.
Oversight for maintaining complex analytical instruments, using knowledge and experience to appropriately respond to performance degradation or malfunctions, scheduling, monitoring, and interfacing with external personnel as necessary.
Ensure all project team deliverables are met for outsourced Quality Control Microbiology work including lot release, stability testing, method validation/transfer/verification, reference standard qualification and analytical comparability.
Continue to build a strong interface to Analytical Development to ensure seamless transfer of analytical methods into QC labs and subsequent phase appropriate validation of such methods.
Establish, own, and lead a global community of practice, using the community to align and standardize microbiology best practices.
Establish a program of periodic audits of the site-based microbiology processes such that processes are assessed for compliance to internal and external standards, that areas for improvement are identified in a timely manner, and real time coaching is provided to staff and risks appropriately raised.
Interface with and build strong collaborative relationships with external stakeholders (CMOs or contract labs) and internal stakeholders including development (upstream, downstream and formulation), CMO and Project Management, Regulatory CMC, and Quality Assurance
Independently resolve technical issues; effectively lead teams with internal and external SMEs to solve issues with broad scope and/or high complexity.
Escalate challenges to management; develop constructive proposals and implement solutions for resolution of challenges.
Ensure compliance within QC by monitoring test methods, SOPs, and QC analytical data to cGMPs, pharmacopeial and regulatory requirements.
As needed review and approve deviations, laboratory investigations and evaluate proposed analytical change requests.
Oversee Quality Control Microbiology contributions to regulatory flings including review of regulatory applications (clinical and marketing applications), review of responses to information requests, and review of briefing documents; develop and implement plans to address gaps based on regulatory feedback or country specific testing requirements.
Lead efforts to harmonize Quality Control Microbiology business processes and SOPs with other company functional areas; ensure SOPs are compliant with applicable regulations while maintaining flexibility and being phase appropriate.
Provide input on budget and resources planning.
Manage Quality Control Microbiology staff including recruiting, onboarding, and performance management.
Implement a program to mentor, coach, train, and identify talent (external/internal) for importation into the program.
Focus on employee engagement by creating a culture of transparent communication, teamwork, and empowerment with a strong focus on career development for Quality Control Microbiology staff.
Develop short-term and long-term goals for Quality Control Microbiology team in alignment with project goals and broader organizational goals; monitor progress against goals.
Skills & Qualifications:
B.S. degree in a scientific discipline.
Advanced degree in biochemistry, chemistry, analytical chemistry, biology, or related field preferred.
Preferred Qualifications:
• At least eight (8) years’ Quality Control Microbiology experience in a GLP/GMP environment, preferable in biotechnology company.
• 5+ years of leadership experience in GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes, and procedures
Skills:
Sample Management, Laboratory, Quality Control, Sample Control, Microbiology, Environmental Monitoring, Bioburden, Endotoxin, Clean Room, Sterility, GLP, GMP, GxP, Stability Program Management, Sterility Coordinator
Top Skills Details:
Sample Management, Laboratory, Quality Control, Sample Control, Microbiology, Environmental Monitoring, Bioburden, Endotoxin, Clean Room, Sterility, GLP, GMP, GxP
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.