We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manufacturing Associate II, cGMP Manufacturing role. The Manufacturing Associate will support facility start-up activities and will be responsible for producing regenerative medicines. This position will be onsite at the manufacturing facility in Morrisville, NC. This position is a non-exempt role and will operate on one of two shifts following a 2-2-3 schedule with the following hours: 7:00am-7:30pm on workdays that occur Sunday through Thursday and 7:00am-5:30pm on workdays that occur on Fridays and Saturdays. Weekends and holidays are required as scheduled. Job Duties and Responsibilities include participating in process validation activities for Sumitomo Pharma America, Inc. new multi-product manufacturing facility; observing and performing critical processing steps and providing real-time feedback; creating, redlining, and reviewing process Standard Operating Procedures (SOPs); developing a suitable level understanding of Sumitomo Pharma America, Inc. GMP manufacturing process(es) and skillfully executing and troubleshooting them; performing inventory control and cycle counts; resolving and reporting issues with product accountability and inventory system discrepancies; executing real-time batch record review; performing alarm monitoring and reconciliation; reviewing and completing documentation to support production activities, including batch record events and management of forms and labels on the production floor; collaborating with stakeholders and customers to resolve production-related issues; conforming to established safety procedures in accordance with OSHA and other regulatory agencies; serving on safety, quality, and other committees if applicable; attending and actively participating in waste walkthroughs, 5S, kaizen events, lean six-sigma, quality, safety, or environmental training/initiatives as required; developing a Subject Matter Expert (SME) level understanding of Sumitomo Pharma America, Inc.’s GMP manufacturing process(es) and skillfully executing and troubleshooting them; assisting with the closure and/or reduction of deviations; performing other activities as required. Key Core Competencies include building strong, open, and collaborative working relationships with both internal and external stakeholders; strong attention to detail; strong problem-solving ability to troubleshoot and communicate appropriately and effectively; ability to work safely and conscientiously in a manufacturing environment; ability to identify and address compliance, environmental, safety, and process deviations as required and escalate to appropriate personnel; and leading tasks to completion. Education and Experience required: minimum of 2+ years of experience in a cGMP manufacturing environment along with a degree in science or a technical related discipline OR a minimum of 3+ years of cGMP manufacturing experience with a high school diploma; prior experience supporting new facility start-up and validation preferred; experience in aseptic operations required; must be able to work in a controlled or clean room environment requiring special gowning including a face mask; background in cell/tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations is strongly desired; experience with batch record execution, including good documentation practices; individuals may be required to sit, stand, walk regularly, and occasionally lift 20-25 pounds. The base salary range for this role is $59,280 to $74,100. Base salary is part of the total rewards package which also includes the opportunity for merit-based salary increases, overtime, short incentive plan participation, eligibility for 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with work state. The robust time-off policy includes up to 120 hours of vacation per year, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter and access to service recognition program. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
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