NovoCart Cell Therapy Manufacturing Manager / 408

Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania.

Position Description:

Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania. Aesculap, Inc., has an excellent opportunity for a NovoCart Cell Therapy Manufacturing Manager. PRIMARY RESPONSIBILITY:Assists in the development of AIS’s cellular therapy manufacturing capabilities. Responsible for coordination and operational management of cellular therapy manufacturing activities. Facilitates technology transfer, process and analytical development, and training activities. SPECIFIC DUTIES:• Supervises operational cellular therapy manufacturing activities.• Assists in development of manufacturing and analytical SOPs, batch records (BRs), and quality systems.• Responsible for staff training at all stages of production and testing: technology transfer, process development and clinical manufacturing.• Works with contract service providers (i.e. contract manufacturing organizations [CMOs], testing laboratories, courier services, etc) to ensure adherence to AIS procedures. • Writes and reviews standard SOPs, batch records, and other documentation.• Assists with the preparation of CMC regulatory submissions.• Serves on AIS project teams.• Performs other duties as assigned.JOB LEVEL:Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways, complete projects as assigned, and achieve goals.EDUCATION/EXPERIENCE:• Bachelor’s Degree in Medical Technology, Biology, or related scientific discipline.• Strong background in cell biology.• Experience with aseptic processing and thorough understanding of FDA GMPs and GTPs.• Experience with clinical trial manufacturing activities, including regulatory submissions• Previous clinical/commercial cellular or tissue processing experience. • Supervisory / management experience.• Ability to prioritize tasks and work on multiple projects simultaneously.• Self-motivated, good leadership and interpersonal skills. SPECIAL REQUIREMENTS:• Must be able to travel by air and car, and work occasional weekends. • Requires excellent written and interpersonal communication skills.• Computer skills in Windows, Word, Lotus e-mail, Excel, and Power Point is desirable.• This position requires the handling of materials that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.SUPERVISION:Ongoing projects are generally self-directed. EQUIPMENT USED IN POSITION: Telephone, personal computer, laser printer, calculator, fax machine, copy machine, an cell therapy manufacturing equipment. PHYSICAL REQUIREMENTS/PHYSICAL ACTIVITIES: Medium Work- position involves ability to frequently or constantly exert up to 20 pounds of force and occasionally exert up to 50 pounds of force to move objects. • Balancing • Climbing • Crouching • Fingering• Hearing • Kneeling • Lifting • Pulling• Pushing • Reaching • Talking • Repetitive Moves• Standing • Stooping • Walking Aesculap is the largest worldwide supplier of surgical instruments and implants for all disciplines including neurosurgery, microsurgery, ENT, plastic and reconstructive, thoracic, micro-vascular, cardiovascular, orthopedic, laparascopic, general surgeries and central processing. We were founded in Germany in 1867 and have been in operation in the U.S. since 1977. Our U.S. corporate office is located in Center Valley, Pennsylvania. Aesculap, Inc., has an excellent opportunity for a NovoCart Cell Therapy Manufacturing Manager.PRIMARY RESPONSIBILITY:Assists in the development of AIS’s cellular therapy manufacturing capabilities. Responsible for coordination and operational management of cellular therapy manufacturing activities. Facilitates technology transfer, process and analytical development, and training activities. SPECIFIC DUTIES:• Supervises operational cellular therapy manufacturing activities.• Assists in development of manufacturing and analytical SOPs, batch records (BRs), and quality systems.• Responsible for staff training at all stages of production and testing: technology transfer, process development and clinical manufacturing.• Works with contract service providers (i.e. contract manufacturing organizations [CMOs], testing laboratories, courier services, etc) to ensure adherence to AIS procedures. • Writes and reviews standard SOPs, batch records, and other documentation.• Assists with the preparation of CMC regulatory submissions.• Serves on AIS project teams.• Performs other duties as assigned.JOB LEVEL:Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways, complete projects as assigned, and achieve goals.EDUCATION/EXPERIENCE:• Bachelor’s Degree in Medical Technology, Biology, or related scientific discipline.• Strong background in cell biology.• Experience with aseptic processing and thorough understanding of FDA GMPs and GTPs.• Experience with clinical trial manufacturing activities, including regulatory submissions• Previous clinical/commercial cellular or tissue processing experience. • Supervisory / management experience.• Ability to prioritize tasks and work on multiple projects simultaneously.• Self-motivated, good leadership and interpersonal skills. SPECIAL REQUIREMENTS:• Must be able to travel by air and car, and work occasional weekends. • Requires excellent written and interpersonal communication skills.• Computer skills in Windows, Word, Lotus e-mail, Excel, and Power Point is desirable.• This position requires the handling of materials that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.SUPERVISION:Ongoing projects are generally self-directed. EQUIPMENT USED IN POSITION: Telephone, personal computer, laser printer, calculator, fax machine, copy machine, an cell therapy manufacturing equipment. PHYSICAL REQUIREMENTS/PHYSICAL ACTIVITIES: Medium Work- position involves ability to frequently or constantly exert up to 20 pounds of force and occasionally exert up to 50 pounds of force to move objects. • Balancing • Climbing • Crouching • Fingering• Hearing • Kneeling • Lifting • Pulling• Pushing • Reaching • Talking • Repetitive Moves• Standing • Stooping • Walking TRAINING REQUIREMENTS:• All training as listed in the training matrix.• The minimum specific training as follows:o Bloodborne pathogenso Cellular therapy product manufacturing, analytical and quality assurance SOPs Aesculap offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension and tuition reimbursement. To learn more about Aesculap and our products, please visit us on the internet at www.aesculapusa.com An EOE.