With a high degree of independence and under limited supervision, the Operations Manager is responsible for the day-to-day laboratory operations of OH-Alive, a platform for automated cell culture manufacturing optimization, tracking of projects through the optimization process, and quality assurance for optimization runs. The operations manager work with the Platform Specialist to track and manage the progress through the optimization process and provide oversight and approval for cell products entering the endpoint analysis stage. This position will provide administrative support, management interface and quality assurance expertise to ensure OH-Alive’s compliance with regulatory and accreditation agencies, and will help design and implement an OH-Alive Quality Plan. This position is expected to interact with customers regularly throughout the optimization process as well as solicit new customers. This position will meet regularly with the Director of Strategic Partnerships/OH-Alive Platform Director to establish overall objectives and to ensure projects are progressing properly and equipment is functioning properly. OH-Alive, a new Ohio Third Frontier Grant awarded September 10, 2012, is an extension of the National Center for Regenerative Medicine (NCRM) Cellular Therapy Service. OH-Alive is located in the Global Cardiovascular Innovation Center (10000 Cedar Avenue Cleveland, Ohio 44106). The goal of OH-Alive is to establish a core facility that houses the expertise and equipment necessary to determine appropriate protocols for producing and releasing cellular therapy materials for clinical trials.
Track and manage automated cell culture manufacturing optimization experiments performed by the Platform Specialist and document progress for customers - GANTT chart tracking is required. Provide quality review of cell optimization runs prior to endpoint analysis. Ensure programmatic compliance including but not limited to cGMP FDA regulation. 40%
Identify and solicit new customers with the OH-Alive business development team and aid in development of customer marketing and education efforts and materials. 20%
Responsible for writing final customer report on the optimized manufacturing method with input from the Platform Specialist. 10%
Collaborate with OH-Alive team on quality improvement projects, reviews and facilitates incident/accident/error reporting with corrective action/follow-up measures. Performs or coordinates internal and external audits and prepares outcomes for presentation at quarterly programmatic quality meetings. (10%)
Write, edit and maintain standard operating procedures and associated forms and worksheets, facilitate reviews and approvals, and ensure protocol compliance. (10%)
Participate in routine competency assessment and continuing education activities. 10%
Serve as a backup operator for the X-Evo, which is comprised of a BioSpherix XVivo and a TECAN Freedom Evo 150 and Quantstudio, a gene array analysis platform.
Perform other duties as assigned.
Department: Regular contact with department supervisors and staff, including the Platform Director/Director of Strategic Partnerships, Platform Specialist, Financial Accountant, Executive Director NCRM, and the PI and NCRM Director
University: Frequent contact with Principal Investigators using the platform
External: Regular contact with the Scientific Director at CCF, Principal investigators from other institutions using the platform, the OH-Alive Steering Board (includes the PI and NCRM Director, individuals from CWRU, University Hospital, Cleveland Clinic Foundation, Athersys, BioSpherix, BioOhio, Nanofiber Solutions and Renovo Neural.
Experience: 5 years in healthcare quality assurance, project management, FDA regulatory and/or clinical laboratory experience is required (experience working in cell therapy and in multiple areas listed above is desired. cGMP and cGTP experience is strongly preferred)
Education/Licensing: Bachelor’s degree in a biological science or business. Master’s degree preferred.
Knowledge and understanding of commonly-used concepts, practices, and procedures within the fields of cell biology, sales and business, and project management.
Knowledge and understanding of commonly-used concepts, practices, and procedures in quality compliance – must have technical experience, knowledge and accuracy.
Ability to detect and communicate deviations in reporting and lab values to co-workers and supervisors.
Ability to run X-Evo platform and Quantstudio for automated cell culture manufacturing optimization method development. Ability to use basic laboratory equipment for cell culture.
Familiarity with policies and procedures of FDA and Quality by Design fundamentals.
Professional and effective verbal and written communication skills.
Strong interpersonal skills; ability to work and communicate with various individuals from a broad spectrum of disciplines, technical and educational backgrounds within the department, school and university, and with individuals outside the university including partners and instrument providers.
Strong organization skills; ability to multi-task, prioritize and meet deadlines. Must demonstrate attention to detail and accuracy, time management skills, and follow-through. Excellent customer service skills; ability to solicit and maintain effective working relationships and address the potential and current needs of customers.
Ability to work effectively independently and collaboratively within a team. Must be highly motivated, responsible, dependable and a self-starter.
Ability to work with sensitive information and maintain confidentiality. New Intellectual Property will be discovered and so this is very important.
Excellent problem-solving skills; must demonstrate excellent analytical skills, sound judgment, good decision-making and innovation.
Must demonstrate flexibility and ability to work under pressure; must be able and willing to work in a fast-paced, changing environment, and conform to shifting priorities, demands and timeline.
Proficiency with software programs such as Microsoft Office (Word, Excel, PowerPoint and Project) and with internet navigation. Ability to learn and apply software programs and applications as needed.
Must demonstrate willingness to learn new concepts, procedures, processes, etc. as needed.
Occasional heavy lifting required. May need to work nights and weekends if necessary to complete process runs or if there is an equipment malfunction.
In employment, as in education, Case Western Reserve University is committed to Equal Opportunity and Diversity. Women, veterans, members of underrepresented minority groups, and individuals with disabilities are encouraged to apply.
Case Western Reserve University provides reasonable accommodations to applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the Office of Inclusion, Diversity and Equal Opportunity at 216-368-8877 to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.