Manufacturing Associate II, cGMP Manufacturing

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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.

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