Sr Manager of Quality Control, Microbiology

Company: Amplifybio, LLC
Location: Grove City
Posted on: May 28, 2023

Job Description:

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!AmplifyBio is a company dedicated to building an integrated environment where clients can access technologies, platforms, capabilities, and safety testing for the scale up and commercialization of advanced therapies. We began as a CRO, spun out from the Battelle organization in West Jefferson, Ohio and are now proud to have added a site in South San Francisco dedicated to discovery, optimization, and characterization of client drug candidates and soon to launch facility in New Albany, OH.The platforms and domain expertise at our New Albany site will fill the critical gap that exists between discovery and the clinical scale up of drug development. The team here is dedicated to helping clients understand the biological and immunological mechanisms and characteristics of their advanced therapies to ensure product consistency and prevent unexpected failures downstream.We partner with our clients, leveraging state-of-the-art technologies and platforms we will enable our customers to accelerate and improve the product development cycle, from concept to commercial.When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians and specialists across a variety of disciplines. Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.AmplifyBios next step forward in advancing medical breakthroughs, treatments, and cures for disease is to establish a Cell & Gene Therapy (CGT) manufacturing and development facility. We are seeking highly motivated individuals to help create and define a first-of-its-kind CGT facility at our new site in New Albany, OH. AmplifyBio is seeking to hire a Senior Manager of Quality Control, Microbiology to join our growing team!!!The Sr. Manager, QC Microbiology is responsible for the day-to-day management of the personnel and work of the QC Microbiology group and the operation of the QC Microbiology laboratory performing microbiological testing (e.g., rapid sterility, mycoplasma, and bioburden tests) for batch release of clients advanced therapeutics including cellular and gene therapy products. The Sr. Manager, QC Microbiology is also responsible for the environmental and utilities monitoring program of multiple cleanroom suites, including establishing EM/UM programs and adapting to a multi-client manufacturing facility, collecting and testing samples, and trend analysis.What Youll Do Here:

• Schedule day to day operations of QC Microbiology personnel and equipment to support the clients manufacturing in the GMP manufacturing facilities.
• Manage microbiological testing services provided to AmplifyBio clients, in support of process development, product manufacturing, product release, and stability evaluation.
• Provide subject matter expertise to enhancement and management of the environmental and utilities monitoring programs to support the maintenance of utilities and cleanrooms in conjunction with AmplifyBio Engineering department to ensure cGMP compliance and state of control.
• Ensure adherence to cGMP practices for QC Microbiology laboratory operations and testing performed by QC Microbiology group.
• Manage timely generation of the periodic reports for cleanroom environment, utilities, and microbial isolates.
• Implement and maintain quality systems and assures their area of responsibilities comply to those system.
• Lead investigations for EM/UM excursions and out of specification results and recommend/assist in implementing appropriate corrective actions.
• Supervise personnel to achieve optimal productivity and proficiency, including setting personnel goals in alignment with department and company objectives.
• Foster an empowering environment where team members develop innovative solutions that improve performance, gains team support for change.
• Assure staff are appropriately trained to perform their work assignments and responsibilities.
• Assure the safety of all staff working within designated spaces, including providing training and oversight of related activities and responding to safety inspections and audits.We Would Love to Hear from You If:
  • Bachelor's degree in microbiology, biological sciences, or related field with at least 8 years of relevant experience and at least 2 years of experience supervising, mentoring, and training personnel.
  • Hands-on experience with microbiological testing for environment and utilities control and monitoring of clean rooms and utilities.
  • Demonstrated leadership and communication skills.
  • Ability to be organized, multitask, communicate effectively with a team of diverse individuals, and a desire to learn new skills.
  • Highly self-motivated with strong work ethic and drive to lead process improvements and capability expansion within designated lab areas.
  • Demonstrated experience in analyzing and interpreting data and information, drawing conclusions and making recommendations and decisions.
  • Excel in a fast-paced team environment, handles multiple tasks concurrently, and delivers in a timely fashion.
  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment.At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. Research shows that oftentimes women and minority groups only apply to open roles if they meet 100% of the listed criteria. AmplifyBio encourages everyone including women, people of color, individuals with disabilities and those in the LGBTQIA+ community to apply for our available positions, even if they don't necessarily check every box on the job description. Hire for attitude and train for aptitude creates unique opportunities to build strong teams of smart, motivated individuals who love what they do. AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law. AmplifyBio will not tolerate discrimination or harassment based on any of these characteristics. If you have a disability or special need that requires accommodation, please let us know during the recruiting process. We are committed to the safety and wellness of our employees and customers. Therefore, COVID vaccination is required.Why You Will Love Working Here:WPI216428923

Keywords: Amplifybio, LLC, Columbus , Sr Manager of Quality Control, Microbiology, Executive , Grove City, Ohio