Manufacturing Associate II (Night Shift)

KBI Biopharma; Durham (NC); On-site; USD 33,062 - 43,050; Full time

Benefits offered by this job

Annual bonus structure

Medical, dental and vision coverage

Paid PTO and holidays

401(k) matching

Employee recognition programs

Job summary

KBI Biopharma in Durham, North Carolina is hiring a Manufacturing Associate I/II for a night-shift position. This role focuses on the processing of bulk intermediates and drug substances, adhering to cGMP and GLP guidelines. Responsibilities include manufacturing per batch records, maintaining aseptic conditions, and documenting processes accurately.

The ideal candidate will possess a relevant degree and have experience in manufacturing operations. KBI Biopharma offers a competitive salary ranging from $24 to $31.25 per hour, along with a comprehensive benefits package including bonuses, medical coverage, and 401(k) matching.

Qualifications

• For Manufacturing Associate II: Bachelor’s degree in related field and 2–5 years experience in cGMP manufacturing operations.
• High school diploma and 4–6 years of experience or equivalent is acceptable.
• Understanding of cGMP applicable to specific tasks.

Responsibilities

• Manufacture bulk intermediates and drug substances per manufacturing batch records.
• Operate in a cleanroom environment with aseptic processing controls.
• Document manufacturing records and logbooks during task execution.

Skills

Basic knowledge of upstream processing – cell culture or fermentation

Experience with single-use platform technology

Education

Bachelor’s degree in a related scientific or engineering discipline

High school diploma with experience

Job description

Position Summary

This role is a night‑shift position on a 2‑2‑3 schedule. The Manufacturing Associate I/II performs upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. All work follows written, approved procedures and forms to ensure Right First Time (RFT) manufacturing under Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). The associate may work independently or as part of a team to author standard operating procedures (SOPs), Master Batch Records (MBRs), write corrective and preventive actions (CAPAs), and specify, commission, and qualify new equipment.

Responsibilities

• Manufacture bulk intermediates and drug substances per manufacturing batch records and current regulations.
• Operate in a cleanroom environment, implementing controls for aseptic processing, including gowning and cleaning procedures.
• Document each task involving manufacturing records and logbooks during execution.
• Use and maintain equipment as per applicable SOP.
• Ensure all materials are issued and accounted for during record execution.
• Apply and understand cGMP and its application to specific tasks.
• Participate in maintaining workplace organization.

Requirements

• For Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline and 2–5 years of experience in cGMP manufacturing operations, or high school diploma and 4–6 years of experience or equivalent.
• Basic knowledge of upstream processing – cell culture or fermentation.
• Experience with single‑use platform technology is preferred.
• Position is night shift and eligible for a shift differential on top of the listed salary.

Salary and Benefits

Salary range: $24–$31.25 per hour. KBI Biopharma provides a comprehensive rewards strategy that includes an annual bonus structure, medical, dental and vision coverage, paid PTO and holidays, a sabbatical program, 401(k) matching with 100% vesting in 60 days, and employee recognition programs.

KBI Biopharma 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. I understand that no representation of KBI Biopharma has the authority to make any assurance to the contrary that this application guarantees any employment offer or employment or that employment can be terminated for any reason without notice.