Manager, QC Microbiology

Manager, QC MicrobiologyAt Minaris Regenerative Medicine our vision is creating future cell therapy miracles together.  We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine.  We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.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. Essential Functions and ResponsibilitiesBelow is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.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.Manages third party testing as needed, including method qualification for microbial assays.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.Other duties as assigned.QualificationsBachelor 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 ProfileCollaboration, accountability, adaptability, can-do, leadership, technical capacity, problem solving, customer-centric, communication, project management, and presentation skillsExcellent 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. Supervisory ResponsibilityCarries out supervisory responsibilities in accordance with the organization's policies and applicable laws.Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions.  Directly supervises the following roles:Microbiology EngineersMicrobiology AnalystsMay also indirectly supervise cross functional employees within the Microbiology department(s)Quality Requirements Build Quality into all aspects of your work by maintaining compliance to all quality requirements.Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).Attend all required Quality & Compliance training at the specified interval.Direct ReportsQC Microbiology AnalystsMinimum Required Training to be Completed within the First 90 Days of HireGxP/GDP TrainingSafety TrainingWorking EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.  Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen.  The noise level in the work environment is moderately noise.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Must have the ability to observe staff in a cleanroom environment for a period of time.Must be able to work in a team-oriented environment.Must have the ability to work with specialized equipment.This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate. Physical RequirementsThe physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.  An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects.Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear.Must be able to exchange information in person, on the telephone, and to make presentations.DisclaimerThe above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.  Duties, responsibilities, and activities may change at any time with or without notice.Monday- Friday (8:00AM-4:30PM)