Manager, QC Microbiology

Job Description:

The Manager, QC Microbiology position is responsible for the oversight and supervision of the QC Microbiology team. In this role, this person will be responsible for management of the Microbiology testing and environment monitoring program at the facility, for completion of quarterly and annual environmental monitoring report, data reviews and approvals and external laboratory management.

Provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance. Provides cross departmental support, as well as collaborating with other departments to support organizational and functional strategy. Develops and/or revises policies and procedures in support of operational excellence initiatives.

Represents Microbiology in internal and external audits which may include interaction with regulatory health authorities and clients. The manager will be responsible for developing new microbiological tests at site with internal and external support.

• Functions as the site Microbiology partner, in collaboration with other stakeholders, ensuring microbiology standards are enforced in compliance with Minaris procedures and regulatory requirements.
• Manage QC Micro-Lab routine operations, including but not limited to EM, microbiological testing, data review, personnel training, and equipment maintenance.
• Support the establishment of a cross contamination strategy for the manufacturing site.
• Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
• Ensure Micro-Lab EHS compliance.
• Ensure timely completion of testing and timely generation of reporting of test results in support of manufacturing operations.
• Coordinates the investigation and closure of deviations with effective root cause analysis for microbiology department to prevent recurrence of such events.
• Drafts/Approves investigation, documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc.
• Ensure that electronic MODA system for environment monitoring is used efficiently to drive compliance and operational excellence.
• Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented, and monitored and effectiveness checks are completed.
• Conducts routine walkthroughs of the microbiology labs, operation facility and supporting areas to ensure compliance with regulatory and quality practices.
• Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
• Supports insourcing of microbiology projects and validations to meet timelines and ensure compliance.
• Involved with the purchase of Microbiology equipment. Support continuous improvement plans or actionable deliverables for microbiology department.
• Participates in the execution of quality system improvement programs and initiatives.
• Support site leadership by ensuring that the QC Micro-Lab meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives.
• Lead by influence and ensure mentoring, motivating, coaching direct reports to higher levels of capability.
• Accountable for fostering team cohesion through an understanding of team dynamics, promoting effective communication, encouraging collaboration, and delivering constructive feedback.
• When necessary, demonstrate leadership through personal example.
• Manage performance and mentor of direct reports.
• Participates in internal audits, regulatory agencies, and client audits.
• Collaborate with senior leadership, peer colleagues, on a regular basis for development and troubleshooting projects.
• Contribute to a culture that embraces continuous learning, development, and collaboration.

Requirements:

Bachelor of Science in biological sciences or other relevant field of study.

5-7 years' relevant microbiology experience in cGMP biotech and/or pharmaceutical environments out of which 2 years of supervisory experience is preferred.

Experience in both clinical and commercial manufacturing is preferred.

Proficient in FDA and EMEA regulations and a working knowledge of root cause analysis.

Understanding of quality system applications, including the training, deviations, CAPA management, etc.

Experience in authoring, reviewing, and/or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)

Experience in organizing and leading teams.

Experience participating in health authority inspections and/or client audits.

Competencies/Candidate Profile:

Collaboration, accountability, adaptability, can-do, leadership, technical capacity, problem solving, customer-centric, communication, project management, and presentation skills.

Excellent verbal and written communication skills, change agility, and problem-solving capabilities.

Demonstrated skills and success in relationship building, negotiation, and influencing (both directly and indirectly).

Ability to independently design, plan, execute and interpret scientific data.

Solid technical knowledge and hands-on experience with microbiology, and/or assay development.

Highly organized and capable of successfully managing multiple priorities using effective time management techniques.

Proven ability to maintain accurate recordkeeping records.

Must be accountable for work product and have a strong work ethic.

Proven ability to define and lead projects, track and execute with quality and timeliness on complex programs of work.