Sr. GMP Manufacturing Engineer, Wake Forest Institute for Regenerative Medicine "Job Details"
Winston-Salem, NC, United States
- Medical Center Blvd, Winston Salem, NC, 27157, US
09/01/2021, 10:56 PM
Atrium Health Wake Forest Baptist is a preeminent academic health system based in Winston-Salem, North Carolina. Atrium Health Wake Forest Baptist’s two main components are an integrated clinical system – anchored by Atrium Health Wake Forest Baptist Medical Center, an 885-bed tertiary-care hospital in Winston-Salem, Brenner Children’s Hospital, five community hospitals, more than 350 primary and specialty care locations and more than 2,500 physicians; and Wake Forest School of Medicine, a recognized leader in experiential medical education and groundbreaking research, including Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery.
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The Sr. GMP Manufacturing Engineer develops and implements methods and performs manufacturing of FDA compliant cell therapy products for clinical implant using cGMP methodology. Performs and develops a variety of moderately complex physical, chemical, or biological operations. Performs validation and verification of equipment and procedures. Provides training and guidance to more junior personnel. Oral and/or written instructions received from supervisor and higher level engineers and technical staff.
EDUCATION / EXPERIENCE
Graduation from a four-year college or university with a major in biomedical engineering, chemical engineering, or a closely related field with specific training or coursework in biotechnology, biomanufacturing, tissue engineering, cell culture, biology, or chemistry, and two or more years’ experience in cell culture, tissue culture, aseptic processing, process development, biomedical engineering, or Good Manufacturing Practices (GMP) methods. GMP and aseptic processing experience highly preferred.
SKILLS AND QUALIFICATIONS
- Excellent recordkeeping and documentation skills.
- Strong verbal and written communication skills.
- Understanding of Microsoft Excel, Word, and ability to master other laboratory analytical computer software.
- Outstanding interpersonal skills, high energy and motivated.
Lead GMP Manufacturing Engineer / GMP Manufacturing Supervisor or Manager / Director of Manufacturing
- Functions independently to execute manufacturing of clinical / medical cell and tissue therapy products for patient implant for multiple Phase I and Phase II clinical trials in the clinical manufacturing facility. Supervises and trains junior level staff in manufacturing of clinical products. Provides administrative support to Director and Assistant / Associate Director.
- Uses specialized education and training to support process development throughout clinical translation by engineering solutions to process needs. Develops methods for analysis of process intermediates and final products for clinical safety and potency.
- Develops and executes studies to move products through clinical translation.
- Develops, implements, and follows standardized production processes including cell/tissue isolation and cell expansion processing, cell cryopreservation and biomaterials manufacture.
- Writes, revises and executes batch records following cGMP documentation guidelines and follows SOPs in support of projects/processes that move into the clinical manufacturing facility.
- Reviews relevant FDA Code of Federal Regulation sections to maintain full GMP compliance.
- Passes stringent GMP gowning and aseptic processing qualifications to attain/verify skill level consistent with working in a GMP environment. Performs qualification of others in aseptic processing.
- Selects and qualifies requisite GMP manufacturing consumables and reagents.
- Attends internal and external seminars, training sessions and workshops to maintain competency in evolving current GMP regulations and job functional requirements.
- Develops and performs processes for equipment and process validation, verification, or qualification.
- Operates a variety of equipment including but not limited to centrifuges, microscopes, biosafety cabinets, incubators and liquid nitrogen freezers.
- Trains lower level personnel on complex equipment functions and manufacturing processes.
- Maintains cleanroom environment in GMP setting by performing scheduled cleaning of equipment and/or manufacturing areas as needed.
- Ensures GMP regulatory compliance via partnership with Quality Assurance, Quality Control, and Facilities Engineering personnel.
- Troubleshoots complex equipment and manufacturing processes with minimum support.
- Supports Facilities, Quality, IT, and Procurement activities required for GMP operation of equipment and processes.
- Takes initiative to identify opportunities for process improvement and implementation.
The Manufacturing Development Center (MDC) is structured to enable the translation and production of tissue engineered products for evaluation in Phase I/II clinical studies in compliance with the current good manufacturing practice regulations (cGMP) as well as the other applicable regulations for biological products and human cells, tissues, and cell and tissue based products.
The MDC clinical manufacturing facility consists of ISO 7 and ISO 8 classified cleanroom space along with an external Quality Control Laboratory, Warehouse, and process development laboratories. Access to all classified areas requires appropriate gowning and aseptic techniques.
Wake Forest Baptist Health and Atrium Health have joined forces in a strategic combination that will enhance care, transform medical education and create economic opportunity for countless lives in North Carolina and beyond. As a part of that combination, the two health systems will be integrating technology and platforms, including our career sites.
This means that although you are applying on the Wake Forest Baptist Health Career Site, you receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process, and thanks in advance for your flexibility.
Wake Forest Baptist Health (www.WakeHealth.edu) is a nationally recognized academic health system in Winston-Salem, North Carolina, with an integrated enterprise including educational and research facilities, hospitals, clinics, diagnostic centers, and other primary and specialty care facilities serving 24 counties in northwest North Carolina and southwest Virginia.
It comprises: a regional clinical system with more than 300 locations, 2,100 physicians and 1,535 acute care beds; Wake Forest School of Medicine; and Wake Forest Innovations, which promotes the commercialization of research discoveries and operates Innovation Quarter, an urban research and business park specializing in biotechnology, materials science and information technology. Wake Forest Baptist’s clinical, research and educational programs are consistently ranked among the best in the country.
About the Team
Wake Forest Baptist Health's mission is to improve the health of our region, state and nation by:
- Generating and translating knowledge to prevent, diagnose and treat disease.
- Training leaders in health care and biomedical science.
- Serving as the premier health system in our region, with specific centers of excellence recognized as national and international care destination.
Wake Forest Baptist Health is a preeminent learning health system that promotes better health for all through collaboration, excellence and innovation.
- Demonstrate the highest standards of patient-centered care, education, research and operational effectiveness
- Responsive to the physical, emotional, spiritual and intellectual needs of all
- Cultivate selfless contribution for the greater good
- Demonstrate fairness, honesty, sincerity and accountability
- Demonstrate respect for and inclusion of all backgrounds, identities, experiences, and perspectives
- Foster mutual respect, facilitate professional growth and mentorship, and reward teamwork and collaboration
- Promote creativity to enhance discovery and the application of knowledge
- Embrace a culture of reliability through better process design and accountability
Patient and Family Promise
We promise to:
- Keep you safe.
- Care for you.
- Involve you and your family.
- Respect you and your time.