Manufacturing Associate II

About the role

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.

Responsibilities

• Participate in process validation activities for Sumitomo Pharma America, Inc. new multi-product manufacturing facility.
• Observe and perform critical processing steps and provide real-time feedback.
• Create, redline, and review 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.
• Perform inventory control and cycle counts.
• Resolve and report issues with product accountability and inventory system discrepancies.
• Execute real-time batch record review.
• Perform alarm monitoring and reconciliation.
• Review and complete documentation to support production activities, including batch record events and management of forms and labels on the production floor.
• Collaborate with stakeholders and customers to resolve production-related issues.
• Serve on safety, quality, and other committees, if applicable.
• Attend and actively participate 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.
• Assist with the closure and/or reduction of deviations.
• Perform other activities as required.

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.
• 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.

Qualifications

• A minimum of a bachelor's degree in a science or technical related field.
• Experience in a cGMP manufacturing environment.
• Experience in aseptic operations.
• Experience with batch record execution.
• Ability to work in a controlled or clean room environment requiring special gowning including a face mask.

Skills

• Strong attention to detail.
• Strong problem-solving ability.
• Ability to work safely and conscientiously in a manufacturing environment.
• Ability to identify and address compliance, environmental, safety, and process deviations as required.
• Leadership skills to lead tasks to completion.

Benefits

• Base salary range: $61,500.00 - $76,900.00
• Merit-based salary increases
• Short incentive plan participation
• Eligibility for 401(k) plan
• Medical, dental, vision, life, and disability insurance
• 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
• Access to service recognition program

Pay

• Base salary range: $61,500.00 - $76,900.00

Schedule

• Onsite at the manufacturing facility in Morrisville, NC.
• 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
  • 7:00am-5:30pm on workdays that occur on Fridays and Saturdays
• Weekends and holidays are required as scheduled.