The Role

Reporting to the Senior Supervisor, Upstream Manufacturing, this specialist role will be a key contributor to manufacturing readiness and future operational output of the Sanford, North Carolina Gene Therapy manufacturing facility. The Manufacturing Associate role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness in 2023. This includes equipment testing, SOP / batch record generation, validation protocol execution support, as well as cross site tech transfer collaboration. Once commissioning and validation is complete, the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing division, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations. 

Primary Responsibilities

• Perform all manufacturing operations under cGMP/ISO requirements
• Display understanding of Upstream process theory (cell growth, transfection, harvest), equipment operation (bioreactors, incubators, tube welders/sealers), and aseptic processing
• Assist with the installation, commissioning, and validation of equipment within single use facility
• Adhere to manufacturing procedures and documentation as well as identifying clarifications or updates when required
• Set up equipment/machines for proper operation, including installation of consumables and disassembly of equipment and parts required for upstream operations
• Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process
• Maintain a high level of quality and compliance with regards to all aspects of manufacturing
• Execute corrective measures addressing any issues in a timely manner
• Assists/writes SOPs (Standard Operating Procedures), batch records, and other GMP documentation
• Ability to identify and escalate potential GMP issues as required
• Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules
• Assists/writes SOPs (Standard Operating Procedures), batch records, and other GMP documentation
• Assist in the evaluation and incorporation of new technologies
• Other duties as assigned

About you

Must Have/Required

• BS in Science or Engineering or equivalent experience
• Strong communicator with ability to work effectively both independently and as part of a team 
• Experience in maintaining detailed records and ability to assist in document revisions
• Understanding of cGMPS as related to commercial and clinical operations
• Strong communicator with ability to work effectively both independently and as part of a team 
• Effective problem-solving skills
• Strong computer skills including MS Office (Word, Excel)
• Proven ability to establish and maintain effective working relationships with team members and managers
• Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

• Associate I: 0-2 years of experience working in a GMP manufacturing environment – applicable certifications are encouraged with no industry work force experience 
• Associate II: 2+ years of experience working in a GMP manufacturing environment
• Associate III: 4+ years of experience working in a GMP manufacturing environment
• Senior Associate: 6+ years of experience working a GMP manufacturing environment in upstream operations
• Technical understanding of a biotech manufacturing facility
• Knowledge of cell culture operations
• Experienced in Startup of a new facility
• Experience with single-use technologies
• Understanding of FDA regulations
• Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency
• Ability to support general investigations and CAPA execution
• Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities