The Operations and Logistics Manager is responsible for the day to day business operation and logistics required for the running of all manufacturing and testing laboratories within the Indiana University Vector Production Facility (VPF), Cell Immunotherapy and Transduction (CIT), Bioprocess Development Laboratory (BDL), and Gene Therapy Testing Laboratory (GTTL). The Operations and Logistics Manager will ensure the standardization and consistency of all standard operating procedures related to cleanrooms, equipment, materials and supplies. Interaction and collaboration with internal and external stakeholders is a key accountability for this position.
It is critical that this position comply with current Good Manufacturing Practice (cGMP) requirements and with FDA and State regulations, including the production of sterile drug products, to ensure the safety of patients receiving these products. Cell and vector manufacturing requires the use of ISO 7 certified cleanroom facilities and ISO 5 certified biological safety cabinets, specialized gowning and personal protective equipment, and aseptic technique. Cleanrooms and equipment must operate according to appropriate standards, including FDA, ISO, and CDC regulations. The Operations and Logistics Manager acts as the point person to ensure all cleanrooms, laboratories, equipment and materials meet required standards allowing staff to perform their duties within the scope of applicable regulations governing the production of biological products for human use. Technical responsibilities include cleanroom operations management, equipment qualification and maintenance management, and materials qualification. This individual will carry a large responsibility for completing documents and data required for reporting. This individual is also responsible for supervising staff and coaching other members of staff in cleanroom operations, equipment management, and materials management.
Master's degree and three years of related manufacturing and/or clinical laboratory operations experience; OR bachelor's degree and five years of related manufacturing and/or clinical laboratory operations experience, including one year of supervisory experience in a laboratory setting.
Combinations of education and related experience may be considered.
Experience in and knowledge of manufacturing and clinical laboratory operations including: cleanroom requirements and function, environmental and equipment monitoring systems, equipment qualification and maintenance, inventory control systems, regulatory requirements, personnel management and project management. Experience in a GMP, or CAP/CLIA environment. Organizing, prioritizing and completing multiple assignments independently. Strong interpersonal and communication skills including skills for communicating with sponsors and regulatory agencies. Ability to function independently and as a member of a large team. Ability to motivate people to achieve excellence. Ability to work with multiple leadership and staffing levels and with multiple business units to achieve Operations management goals. Ability to train and manage personnel. Proficient in Microsoft Office Suite, including Word, Excel, Outlook and Project.
Experience with project management software and maintenance and development of electronic databases.
Working Conditions / Demands
Requires reliable attendance. Ability to lift 50 pounds at a time, lift or carry objects weighing up to 25 pounds frequently. Will spend moderate periods of time standing to receive in and store supplies appropriately. Ability to travel among all facilities, including R2, R3 and University Hospital on a regular basis. Degree of sight required to allow inspection of incoming supplies and associated documentation.
Must be able to perform essential functions of job with or without an accommodation.
Salary Plan: PAE
Salary Grade: 4AD
Job Function: General Admin
This posting is scheduled to close at 11:59pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
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Equal Employment Opportunity
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Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.