Manufacturing Associate II

Sumitomo Pharma • Morrisville, NC

4d • Onsite

About The Position

Sumitomo Pharma America (SMPA) is 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.

Requirements

• 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.
• Experience in aseptic operations required.
• Must be able to work in a controlled or clean room environment requiring special gowning including a face mask.
• 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.
• Requires a high level of initiative and independence.
• Excellent written and oral communication skills required.
• Requires ability to use a personal computer for extended periods of time.

Nice To Haves

• Prior experience supporting new facility start-up and validation preferred.
• Background in cell/tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations is strongly desired

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.

Benefits

• opportunity for merit-based salary increases
• overtime
• short incentive plan participation
• eligibility for our 401(k) plan
• medical, dental, vision, life and disability insurances
• leaves provided in line with your work state
• up to 120 hours of vacation per year
• 11 paid holidays
• 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
• access to our service recognition program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED