Senior Manager, QC Microbiology

Sr. Manager, QC Microbiology

At 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 Quality Control (QC) Microbiology Sr. Manager plays a pivotal role in ensuring that the QC Microbiology team is effectively serving in its support role to clinical and commercial production. This role will oversee environmental monitoring of classified spaces and clean utilities and associated excursion investigations, microbiological testing of Raw Materials, Intermediates and Finished Products, training of staff on aseptic techniques, interacting with regulatory inspectors and clients with regards to microbiological topics and further development of microbial and environmental control procedures and policies. This role will certify that quality standards are upheld for all processes and products produced at the Minaris facility. The goal is to ensure that the QC Microbiology group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines.

The incumbent will also utilize his or her technical expertise, knowledge of pharmaceutical testing (e.g critical issues involved in test methods, laboratory instrumentation & basic principle (s) of operation), current regulatory guidelines, ample organizational and communication skills to ensure safe, efficient and effective laboratory operations. This is a critical role within the QC Microbiology department that oversees the activities performed in the team are as per applicable rules and regulations.

Essential Functions And Responsibilities

Below is the summary of the role responsibilities for this position. 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.

• Define and implement microbial techniques in order to verify the quality of raw materials, intermediate, end products, and stability as well as any other microbial services relevant to our client base and according to regulatory requirements.
• Perform trending and data analysis with appropriate statistical evaluation of environmental monitoring for Minaris facility sites and writes quarterly trend reports summarizing these data.
• Manage and control all QC Microbiology activities in accordance with identified quality standards, company procedures, contract requirements, ensuring compliance with FDA, Annex 1, and other regulatory requirements.
• Work with and provide input to Operations and Facilities groups to maintain the sterility or aseptic nature of processes.
• Represent the Microbiology group in facility commissioning and/or expansion efforts.
• Validate methods and ensure all testing procedures are performed in accordance with established protocols.
• Coordinate and support validation, calibration, and maintenance of microbiology laboratory equipment and instrumentation
• Plan, coordinate and supervise the work, with other managers of the area, and manage own team to ensure that the deliverables of each project are dealt in the team within the timeframes defined, with the appropriate quality and according to cGMP and that an outstanding service is provided to all customers (internal and external)
• Interface with Regulatory Agency Inspectors/Auditors, Client Audits, and participate in external and internal audits. Ensure that corrective and preventative actions are defined and implemented as a result of observations from audits.
• Provide analysis of opportunities for operational improvement in the QC Microbiology department for Deviations, Corrective and Preventative Actions and Change Control relative to Minaris goals. Manage the general operation and workflow of all QC Microbiology related compliance records.
• Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings
• Serving as approver (FAM) in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records
• Participate in BLA filings by providing review and compilation of Microbial data required for filings.
• Author complex documents (i.e., Trend Reports, APRs, validation/verification and qualification protocols and reports etc.) and microbial risk assessment including Contamination Control Strategy.
• Approve microbial test methods, reports, protocols and other documents related to the laboratory (as applicable)
• Assure the qualification of the laboratory equipment and validation of microbial methods, approving the protocols and/or respective reports
• Ensure proper management of all defined sterility programs in terms of microbiology testing execution and data release
• From project teams and champion the execution of agreed projects using project management, problem-solving and operational excellence tools
• Coach and mentor team members on best practices, regulatory requirements, and troubleshooting techniques.
• Identify and implement KPIs or other appropriate metrics (as needed) to monitor progress and benefit of projects and initiatives
• Communicate and maintain trust relationships with senior management, business partners, and clients
• Ensure company policies and legal guidelines are communicated top-down in the company and that they are followed at all times.
• Evaluate and investigate customer complaints and deviations; coordinating corrective and preventive actions as they relate to the QC Microbiology function
• Oversee development, revisions, and implementation of Standard Operating Procedures as related to QC Microbiology activities.
• Keep up to date on new analysis techniques relevant to the laboratory, by means of literature, training, seminars or conferences
• Provide strategic direction and identify key opportunities to innovate and transform business processes
• Lead strategy to simplify & standardize equipment software architecture, enabling digital integration.
• Contribute to departmental performance and quality initiatives, emerging as a leader
• Identify and execute Continuous Improvement Projects for the department. Lead and develop best practices in the laboratory
• Assure the timely execution of the preventive maintenance program and execution of corrective maintenance
• Prioritize, schedule, and manage multiple projects and resources simultaneously
• Lead equipment life cycle management & asset/investment optimization process. Evaluate and purchase equipment based on S&OP demand within the aliquoted budget.
• Perform project portfolio management and budget management for QC Microbiology Operations
• Work with the BD group for initiation of W.O. for any out-of-scope work done for the clients.
• Participate in budgeting and forecasting for the lab. Routinely tracks group budget and cost containment drives.
• Complete projects and special tasks as assigned
• Assure alignment and efficient continuity in laboratory practices between sites
• Delegate responsibilities and supervise the work of laboratory personnel, while providing guidance and motivation to drive maximum performance. This role will also manage and motivate team members, build trust, and cultivate a collaborative environment.
• Devise sound hiring strategies, developing, training, and evaluating QC Microbiology personnel based on business needs. Leads teams and cross-functional project teams and drives team performance and results.
• People and talent management of the team with focus on diversity and inclusion.
• Any other assigned task by management to support business
  
  

Qualifications

• BA/BS/MS in a Life Science or relevant field required
• Prior cGMP experience in QC Microbiology laboratory, aseptic manufacturing, or Clean room environment experience in a cGMP environment a must; Commercial experience in QC Microbiology Laboratory is preferred.
• Requires 10 years of relevant experience in a Management of Microbiology Lab preferably in a GMP environment within the Cell & Gene Therapy, pharmaceutical, biologics or related industry
• Working knowledge of routine QC Microbiology laboratory procedures such as mycoplasma, sterility (USP and rapid), environmental monitoring, endotoxin testing, equipment and systems.
• Proficient in statistical and data analysis
• Up-to-date knowledge in USP/ISO/ICH/FDA /EU/JP/cGMP/Safety regulations would be added advantage
• Strong understanding of QC Microbiology in Cell & Gene Therapy/pharmaceutical/biotechnology/biologics industries
• Experience with GMP Equipment qualification processes is required
• Strong knowledge in Method qualification and validation is required.
• Must have experience in root cause analysis and proven track of implementing corrective/preventative actions commensurate with level of Quality and Compliance Risk
• Experience in internal and/or external audits
• Must be able to effectively prepare reports with high level of precision, communicate data analysis to management and others within group with clarity and accuracy and provide guidance to others in technical interpretation of data.
• Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking
• Proven track record for implementing and leading change.
• Demonstrable experience in developing strategic plans based on business needs
• Lean Six Sigma or other Process Excellence certification preferred
• Proven people management experience with ability to lead, coach, and motivate employees.
• Clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position
• Proficient with computer software such as MoDA, Microsoft Office, Istability, Visio, etc.
• Strong knowledge of QC Microbial testing methodologies, philosophies, method
• validation and method transfers.
• Strong knowledge of quality systems and ability to interpret Quality standards for
• implementation and review.
  
  

Competencies/Candidate Profile

• Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner.
• Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.
• Excellent organizational and leadership skills.
• Excellent communication, interpersonal, and presentation skills.
• Outstanding analytical and problem-solving abilities.
• Thorough knowledge of market changes and forces that influence the company.
• Strong influencing skills, able to lead change and transform business processes with a strong implement decision and to gain support for ideas and their vision
• Effective time management skills and the ability to multitask
  
  

Supervisory Responsibility

• Carries 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:
• QC Microbiology Associates (I to IV), QC Microbiology investigators, QC Microbiologist. QC Team Leaders , QC Microbiology Supervisors, etc.
• Provide support for Manufacturing processes.
  
  

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.
  
  

Minimum Required Training

• GMP Training.
• Quality Systems Training (Deviation/CAPA/Change Control).
  
  

Working Environment

• While 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.
• Must have the ability to work in a team-oriented environment and with clients
• Must have the ability to work in the cleanroom environment for extended period of time
• Must have the ability to work with specialized equipment
• Must be able to handle the standard/moderate noise of the manufacturing facility
• 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
  
  

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.

• Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen.
• The employee is frequently required to lift, move, or carry up to 30 pounds
• Gowning proficiency as needed.
• Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.
• Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
• Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.
  
  

Disclaimer

The 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)