Manufacturing Associate II

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com ]   Job Overview   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  •    Participate in process validation activities for Sumitomo Pharma America, Inc. new multi-product manufacturing facility.  •    Observes and performs critical processing steps and provides real-time feedback.  •    Create, redlines, and reviews process Standard Operating Procedures (SOPs).  •    Develop a suitable level understanding of Sumitomo Pharma America, Inc •    GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.   •    Performs inventory control and cycle counts. Resolves and reports issues with product accountability and inventory system discrepancies.  •    Executes real-time batch record review. Performs alarm monitoring and reconciliation.  •    Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the production floor.  •    Collaborates with stakeholders and customers to resolve production-related issues.   •    Conforms to established safety procedures in accordance with OSHA and other regulatory agencies.  •    Serves on safety, quality, and other committees, if applicable.  •    Attends and actively participates in waste walkthroughs, 5S, kaizen events, lean six-sigma, quality, safety, or environmental training/initiatives, as required.  •    Develop a Subject Matter Expert (SME) level understanding of Sumitomo Pharma America, Inc.’s GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them.   •    Assists with the closure and/or reduction of deviations.  •    Performs other activities as required.    Key Core Competencies  •    Build strong, open, and collaborative working relationships with both internal and external stakeholders.  •    Strong attention to detail.  •    Demonstrates a 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 addresses compliance, environmental, safety, and process deviations as required and escalates to appropriate personnel.  •    Leads tasks to completion.    Education and Experience  •    A 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 is required.  •    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.  •    Must be able to work in a controlled or clean room environment requiring special gowning including a face mask.  •    Individuals may be required to sit, stand, walk regularly, and occasionally lift 20-25 pounds.  The base salary range for this role is $61,500.00 - $76,900.00 Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, overtime, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our 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 our 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 . Disclaimer: The above statements are i