Job Description

Rx Group is recruiting for an Associate Director, Quality Control Microbiology for a clinical stage gene therapy biotech in Florida. The role is an on-site position.

The Associate Director, QC Microbiology will be responsible for oversight of all activities in the Quality Control and Microbiology laboratories. This includes oversight of projects both internally to the company as well as with external partners and contractors. In collaboration with manufacturing, they will set requirements for raw materials from suppliers. Additionally, they will establish metrics for assay performance.

Duties and Responsibilities

• Manage Quality Control Microbiology staff including recruiting, onboarding, and performance management.
• 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.
• 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.

Educational Qualifications

• B.S. degree in Microbiology
• Advanced degree in biochemistry, chemistry, analytical chemistry, biology, or related field preferred.

Additional Qualifications

• At least eight (8) years’ Quality Control Microbiology experience, (10-12 preferred) in a GLP/GMP environment, preferable in biotechnology company.
• 5+ years of people management experience with proficiency in establishing objectives, monitoring performance, providing feedback, and developing staff.
• In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes, and procedures
• Great attention to detail
• Strong interpersonal skills
• Strong prioritization, organizational and negotiating skills.
• Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
• Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines.

Please apply directly for this role or contact Hemish Ilangaratne at h.ilangaratne@rx-group.io if interested.