KBI Biopharma
KBI: US - Senior Manufacturing Associate I (Nights)
KBI Biopharma, Durham, North Carolina, United States, 27703
KBI: US - Senior Manufacturing Associate I (Nights)
Apply for the
KBI: US - Senior Manufacturing Associate I (Nights)
role at
KBI Biopharma .
Job Summary The Senior Manufacturing Associate I (or II) is responsible for the execution of upstream or downstream production activities for early and late‑phase cell‑culture programs within a GMP environment. The role involves following all documentation, SOPs, and regulatory requirements to ensure compliant, quality‐driven manufacturing. The successful candidate will bring both technical knowledge and a quality‑mindset to support precision, continuous improvement, and robust record‑keeping for all production activities.
Responsibilities
Manufacture cell culture products per batch records in compliance with quality standards, company policies, and current regulations (≈25% of time).
Perform operations in a cleanroom environment, applying aseptic controls including gowning and cleaning procedures (≈15% of time).
Document each manufacturing task (SRs, EPRs, BRs) at the time of execution following GDP (≈15% of time).
Operate and maintain equipment per applicable SOP, ensuring all items are issued and accounted for (≈20% of time).
Demonstrate, apply, and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks (≈10% of time).
Participate and be accountable for 5S activities (≈10% of time).
Provide direction and guidance to Manufacturing Associates I and II, and help the supervisor distribute workload and ensure all team members understand task requirements (≈10% of time).
Support continuous improvement by identifying process and record improvement opportunities and communicating them to the appropriate stakeholders (≈10% of time).
Minimum Requirements
Bachelor’s degree in a related scientific or engineering discipline with 4–6 years of experience in GMP manufacturing operations; or high school diploma with 7–10 years of experience. (Senior Manufacturing Associate I)
Bachelor’s degree with 5+ years of GMP manufacturing experience; or high school diploma with 10+ years of experience. (Senior Manufacturing Associate II)
Demonstrated knowledge of cell culture, fermentation, or purification unit operations (preferred).
Experience with single‑use platform technology (preferred).
Excellent written and verbal communication skills; energetic, motivated, and organized to maintain operational efficiency in a fast‑paced environment.
Fluent in English (reading, writing, speaking).
Ability to solve practical problems, interpret instructions, and handle basic math and data interpretation tasks.
Proficiency in MS Office, ERP, EDMS, and production equipment software.
Familiarity with biosafety cabinets, incubators, single‑use bioreactors, chromatography columns, ultrafiltration skids, filling systems, and relevant analytical instruments.
Working Conditions The position requires 12‑hour shifts, including overnight hours, within a cGMP biopharma manufacturing facility that requires cleanroom attire and strict hygiene practices. Employees will regularly use equipment and materials that involve mechanical, chemical, and electrical hazards, along with tripping/falling risks. Noise levels are moderate to high. Physical demands include standing up to 50% of the time, lifting and carrying up to 45–50 lbs., pushing up to 450 lbs., and using ladders or step stools for certain operations.
EEO Statement KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status, are strongly encouraged to apply.
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KBI: US - Senior Manufacturing Associate I (Nights)
role at
KBI Biopharma .
Job Summary The Senior Manufacturing Associate I (or II) is responsible for the execution of upstream or downstream production activities for early and late‑phase cell‑culture programs within a GMP environment. The role involves following all documentation, SOPs, and regulatory requirements to ensure compliant, quality‐driven manufacturing. The successful candidate will bring both technical knowledge and a quality‑mindset to support precision, continuous improvement, and robust record‑keeping for all production activities.
Responsibilities
Manufacture cell culture products per batch records in compliance with quality standards, company policies, and current regulations (≈25% of time).
Perform operations in a cleanroom environment, applying aseptic controls including gowning and cleaning procedures (≈15% of time).
Document each manufacturing task (SRs, EPRs, BRs) at the time of execution following GDP (≈15% of time).
Operate and maintain equipment per applicable SOP, ensuring all items are issued and accounted for (≈20% of time).
Demonstrate, apply, and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks (≈10% of time).
Participate and be accountable for 5S activities (≈10% of time).
Provide direction and guidance to Manufacturing Associates I and II, and help the supervisor distribute workload and ensure all team members understand task requirements (≈10% of time).
Support continuous improvement by identifying process and record improvement opportunities and communicating them to the appropriate stakeholders (≈10% of time).
Minimum Requirements
Bachelor’s degree in a related scientific or engineering discipline with 4–6 years of experience in GMP manufacturing operations; or high school diploma with 7–10 years of experience. (Senior Manufacturing Associate I)
Bachelor’s degree with 5+ years of GMP manufacturing experience; or high school diploma with 10+ years of experience. (Senior Manufacturing Associate II)
Demonstrated knowledge of cell culture, fermentation, or purification unit operations (preferred).
Experience with single‑use platform technology (preferred).
Excellent written and verbal communication skills; energetic, motivated, and organized to maintain operational efficiency in a fast‑paced environment.
Fluent in English (reading, writing, speaking).
Ability to solve practical problems, interpret instructions, and handle basic math and data interpretation tasks.
Proficiency in MS Office, ERP, EDMS, and production equipment software.
Familiarity with biosafety cabinets, incubators, single‑use bioreactors, chromatography columns, ultrafiltration skids, filling systems, and relevant analytical instruments.
Working Conditions The position requires 12‑hour shifts, including overnight hours, within a cGMP biopharma manufacturing facility that requires cleanroom attire and strict hygiene practices. Employees will regularly use equipment and materials that involve mechanical, chemical, and electrical hazards, along with tripping/falling risks. Noise levels are moderate to high. Physical demands include standing up to 50% of the time, lifting and carrying up to 45–50 lbs., pushing up to 450 lbs., and using ladders or step stools for certain operations.
EEO Statement KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status, are strongly encouraged to apply.
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