Manufacturing Associate II

About the Company

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with operations in the United States focused on oncology, urology, women's health, rare diseases, cell and gene therapies, and central nervous system disorders. The company has marketed products and a diverse pipeline of early‑to‑late‑stage investigational assets that accelerate discovery, research and development to bring novel therapies to patients sooner.

Manufacturing Associate II, cGMP Manufacturing – onsite at the Morrisville, NC facility. This non‑exempt role supports facility start‑up activities and produces regenerative medicines, operating on one of two shifts with a 2‑2‑3 schedule (Sunday‑Thursday 7:00am‑7:30pm; Friday‑Saturday 7:00am‑5:30pm). Weekends and holidays are required as scheduled.

• Participate in process validation activities for the new multi‑product manufacturing facility.
• Observe and perform critical processing steps while providing real‑time feedback.
• Create, redline, and review Standard Operating Procedures (SOPs).
• Develop a deep understanding of GMP manufacturing processes and execute and troubleshoot them skillfully.
• Perform inventory control and cycle counts, resolving and reporting discrepancies.
• Execute real‑time batch record review and alarm monitoring with reconciliation.
• Review and complete documentation to support production activities, including batch record events and management of forms and labels.
• Collaborate with stakeholders and customers to resolve production‑related issues.
• Conform to safety procedures in accordance with OSHA and regulatory agencies.
• Serve on safety, quality, and other committees when applicable.
• Attend and participate in waste walkthroughs, 5S, kaizen events, lean Six‑Sigma, quality, safety, and environmental training initiatives.
• Develop subject‑matter‑expert level understanding of GMP manufacturing processes and troubleshoot them.
• Assist with closure or reduction of deviations.
• Perform other activities as required.

• Build strong, open, and collaborative relationships with internal and external stakeholders.
• Strong attention to detail.
• Demonstrate strong problem‑solving ability to troubleshoot and communicate effectively.
• Work safely and conscientiously in a manufacturing environment.
• Identify and address compliance, environmental, safety, and process deviations and elevate to appropriate personnel.
• Lead tasks to completion.

Minimum requirements:

• 2+ years of cGMP manufacturing experience with a science degree or 3+ years with a high‑school diploma.
• Preferred experience supporting new facility start‑up and validation.
• Experience in aseptic operations and in clean‑room environments (ISO7/8, BSCs, isolators).
• Background in cell/tissue culture, qualification of aseptic suite and gowning procedures.
• Experience with batch record execution and good documentation practices.

Additional qualifications: Ability to work in a controlled or clean‑room environment with special gowning, including a face mask; ability to sit, stand, walk regularly and lift 20‑25 pounds as needed.

The base salary range for this role is $61,500.00 – $76,900.00. Total rewards include merit‑based increases, overtime, short incentive plan participation, 401(k) eligibility, medical, dental, vision, life and disability insurance, and paid time off. Vacation: up to 120 hours per year, 11 paid holidays, additional shut‑down holiday time, and 80 hours of paid sick leave upon hire and each subsequent year.

These statements describe the general nature of the role and are not an exhaustive list of responsibilities or qualifications. Duties may be added or removed as needed.

All information encountered by employees is confidential in accordance with applicable law.

Maintain compliance with all regulatory, legal and operational rules by following best industry practices and the highest ethical standards.

Fast‑paced environment with multiple demands. Requires initiative, independence, strong written and oral communication, and effective use…