Microbiology Supervisor

Welcome to DiscGenics, a pioneering, late-clinical stage biopharmaceutical company dedicated to advancing regenerative cell-based therapies for patients suffering from degenerative diseases of the spine. Privately held and passionately driven, our mission is to enhance lives by alleviating pain and restoring function through innovative treatment.

At DiscGenics, we are committed to improving the quality of life for individuals debilitated by degenerative diseases of the spine. Our focus lies in developing cutting-edge therapies that offer hope and tangible results, fostering a future where patients can regain mobility and comfort.

Our team is characterized by a relentless pursuit of excellence and a nimble approach to addressing challenges. Our core values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship guide everything we do.

Join us at DiscGenics and be part of a transformative journey where your contributions have the potential to impact the lives of millions. Together we innovate with purpose and compassion, striving towards a future where pain and limitations of degenerative spine diseases are a thing of the past.

Discover more about us at discgenics.com and see how you can contribute to revolutionizing patient care through regenerative therapies.

The Microbiology Supervisor is responsible for managing operations and personnel. In this role, the Supervisor will establish and maintain the environmental monitoring and will provide guidance to further develop and maintain the facility disinfection program, facility design and finishes, facility validation, sterility assurance and quality assurance initiatives.

This role interacts with all levels of the organization in a collaborative and positive way with colleagues to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values.

Essential Duties and Responsibilities:

• Supports other Departments in DiscGenics to enable quality by design.
• Conduct training on microbiological processes, GMP, and GDP.
• Supports the implementation and maintenance of the Quality Management System (QMS) processes.
• Work to establish a training program and trainer qualification program.
• Draft and implement SOPs and templates related to the microbiological department.
• Recruit, train, and supervise microbiology lab personnel in environmental monitoring and product release testing activities.
• Conduct training in environmental monitoring, microbiological product testing, aseptic technique, and related topics.
• Develop and maintain facility disinfection program for cleanrooms, and manage disinfection efficacy studies
• Assist with development of site microbial reduction strategy.
• Support validation of clean rooms and utilities (HVAC, compressed air, water system, etc.) and cleanroom cleaning processes.
• Other duties as assigned.

Job Requirements:

• Proficient with Microsoft Office, including Word, Excel and PowerPoint. Possesses high-level of understanding of cGMP/GDP/GLP regulations.
• Strong interpersonal, communication (verbal and written), organizational and project management skills.
• Familiarity with relevant FDA, ICH, USP, EP, AAMI, and ISO guidelines and regulations associated with the quality control of cell therapy drug and combination products.
• Experience in use of various classical microbiology techniques such as serial dilution, growth promotion, Gram stain, streak plate, spread plates, bioburden, and biological indicators.
• Experience with environmental monitoring programs and testing.
• Strong attention to detail.
• Ability to think proactively.
• Ability to handle highly confidential business information.
• Exceptional time management and multi-tasking skills.
• Team leadership skills and team player.
• Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship.
• Regular and predictable attendance.
• Ability to report to work unimpaired.

Education and Experience:

• Bachelor’s degree in the Microbiological Sciences, or related field.
• A minimum of 5 years’ experience in environmental monitoring and microbiology techniques in an aseptic manufacturing facility.
• 3 years laboratory supervisory experience

Working Conditions:

Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes.

Must be able to lift and carry up to 20 pounds.

Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.

Disclaimer:

Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.