A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. We are seeking a qualified Microbiology Manager who will be responsible for leading all aspects of microbiological assay and Environmental Monitoring activities to support client processes and manufacturing activities, ensuring compliance with the established SOPs, cGMP, and all regulatory agencies. He/she will need to provide leadership at all levels of the organization as well as communicate and embody the company vision and values.
This role will be overseeing our Microbiology/Environmental Monitoring (EM) teams that perform EM testing, raw material qualification and testing, stability testing, microbiology testing and in-process testing associated with the production of our products. The candidate must possess a deep understanding of the pharmaceutical development processes from pre-clinical development through the life-cycle management as well as clean room flows and aseptic techniques. The selected candidate will be fully engaged with cross-functional teams seeking to develop new microbiological assays to support and enhance company’s assay platforms.
As a Microbiology Manager, you will maintain and drive comprehensive quality metrics, including developing and driving appropriate performance Key Performance Indicators (KPIs), managing timelines and working with various stakeholders to successfully deliver customer deliverables, while helping to maintain our production environment in a state of readiness. You will effectively lead, track and trend the Microbiology and Environmental Monitoring Program at the Carlsbad site as well as initiating and driving change, while interfacing with internal and external clients and developing the a best-in-class Microbiology/EM team. The successful candidate needs to demonstrate success/experience developing staff at all levels of the organization.
This role willalso be the primary scientific resource and subject matter expert for the Microbiology and EM team for the site. He or she will be the primary expert in providing technical advice and support for internal and external interactions during client and regulatory audits/inspections, meetings, and teleconferences. The role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships, including both internal and external stakeholders.
ESSENTIAL JOB FUNCTIONS
- Lead, manage and develop the Microbiology/EM team that supports the daily operations of the Manufacturing and Process Development group
- Ensure QC labs compliance with ISO, FDA, cGMP, EMA and Millipore requirements
- Develop and report on Quality metrics for the Microbiology and EM testing (raw material and in-process testing). Ensure that those metrics are met, that lab performance is continually improving, and that metrics are communicated throughout the site as appropriate
- Perform analysis and interpretation of data generated by the team. Prepare/ review protocols and final reports as needed
- Support/ participate new product transfers into Manufacturing. Develop and execute plans for test method qualification, component qualification criteria, raw material sampling plan and adherence to the Product Development Process (PDP) system
- Drive implementation of new services. Keep abreast of potential new technologies to enable the design of new assay and test methods
- Liaise with Quality Assurance and appropriate cross-functional departmental areas to leverage knowledge and experience not being available in house
- Create/Revise SOPs, laboratory records and other related documentation
- Maintain fluency with evolving global regulatory requirements and industry standards for microbiological, EM testing, clean room requirements and characterization of biological products
- Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes and equipment. Coach/ train others on developing and enhancing day to day laboratory techniques
- Provide technical advice and support for internal and external interactions such as client and regulatory audits/inspections, meetings, teleconferences
- Responsible for employee coaching and development, determining employee responsibilities, evaluating and managing performance as appropriate
- Build up the company by recruiting, interviewing, hiring, and mentoring new talent
- Promote a culture of continuous improvement within Method Development and Quality Control; act as champion on initiatives to drive improvement in quality and client services
- Comply with company EH&S requirements. Promote a safety first culture
- Prioritize tasks to ensure that projects are completed by deadlines and streamlining processes to maximize productivity
Who You Are:
- BS degree or higher in a Life Science discipline or equivalent. MA/MS or PhD preferred
- Minimum of 5 years of experience in Quality Control and CMO environment
- Previous leadership/supervisory experience is required
- Experience with cGMP, aseptic techniques, automation, troubleshooting for machineries, equipment, software and data integrity
- Strong foundation in Lean Manufacturing and Continuous Improvement
- Strong command of quality systems supporting ISO 9001 and 134585 certification as well as FDA regulations (such as 21CFR11)
- Good understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals as well as compendial methods
- Excellent technical expertise in Microbiology and Environmental Monitoring fields
- Ability to work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities
- Proven ability to establish direction and obtain commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity
- Previous experience of utilizing and/ implementing electronic Microbiology/EM software (MODA or Novatek or equivalent) is required
- Excellent communication, organization, analytical and technical writing skills
- Working knowledge of validations, calibration systems, process design, design of experiment, instrumentation, automation, and digitization/paperless system
- Operational knowledge of the regulation (cGMP, ISO, EMA) and directives, and liability for non-compliance
- Possess understanding of group dynamics and have the ability to effectively influence group decision-making process. Ability to make thoughtful, integrated, timely and meaningful recommendations and/ decisions and take corresponding actions
- Strong oral and written communication skills, discretion and confidentiality required to interface with sensitive employee relations
- Ability to analyze past and current performance and recommend objectives to improve productivity and increase efficiency
- Thorough knowledge of method development, qualification and validation and method transfer principals
ADDITIONAL LOCAL NEEDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties, the employee is:
- Constantly required to sit and reach to use computers and other office/lab equipment
- Occasionally stand for extended periods of time, up to four (4) to five (5) hours/time
- Occasionally required to lift up to fifty (50) pounds
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
Employee frequently works in a professional office environment and lab with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct off- shift, weekend, and overtime duties may be required as assigned by the manager of the employee,
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