Manufacturing Associate I/II- Downstream

Kbi Biopharma • Durham, NC

387d • $55,016 - $75,920

About The Position

The Manufacturing Associate I/II is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. This role requires adherence to Good Manufacturing Practice (GMP) and involves working both individually and in teams to ensure compliance with established procedures. The position is a night shift role with a 2-2-3 rotation, emphasizing a strong sense of ownership and collaboration across various departments to ensure successful manufacturing operations.

Requirements

• Manufacturing Associate I: Bachelor's degree in a related scientific or engineering discipline and 0-2 years' experience in related cGMP manufacturing operations; or high school degree and 3-5 years' experience, or equivalent.
• Manufacturing Associate II: Bachelor's degree in a related scientific or engineering discipline and 2-5 years' experience in related cGMP manufacturing operations; or high school degree and 4-6 years' experience, or equivalent.
• Basic knowledge of upstream (cell culture or fermentation), downstream (purification and bulk filling) or manufacturing support unit operations is preferred.
• Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills are required.

Nice To Haves

• Energetic, motivated, and dynamic individual.
• Ability to focus in a fast-paced, multi-tasked environment.
• Strong attention to detail and superior integrity and accountability.

Responsibilities

• Perform upstream or downstream processing of bulk intermediates and/or bulk drug substances.
• Follow written, approved procedures to ensure compliance with Good Manufacturing Practice (GMP).
• Work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs).
• Write corrective and preventive actions (CAPAs).
• Specify, commission, and qualify new equipment as needed.
• Execute daily tasks while maintaining strict adherence to manufacturing records, SOPs, and GMP.
• Review executed production records and logbooks for GxP compliance.
• Collaborate cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, and other departments.

Benefits

• Annual bonus structure for all employees.
• Medical, dental, and vision coverage.
• Paid PTO and holidays.
• Sabbatical program.
• 401K matching with 100% vesting in 60 days.
• Employee recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees