Manufacturing Associate II (Night Shift)

NCBiotech; Durham (NC); On-site; USD 50,000 - 65,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, and vision coverage

PTO and holidays

Sabbatical program

401K matching

Employee recognition programs

Job summary

KBI Biopharma, Inc. seeks a Manufacturing Associate I/II to perform upstream or downstream processing of bulk intermediates and drug substances on a 2-2-3 night shift, following GMP/GLP as required.

The role emphasizes Right First Time production, documentation, and cross-functional collaboration with QA, MS&T, facilities, and engineering. The candidate should hold a Bachelor’s in a related field with cGMP experience, or a high school diploma with substantial related manufacturing experience.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 2-5 years of cGMP manufacturing experience.
• Basic knowledge of upstream processing—cell culture or fermentation.
• Experience with single-use platform technology is preferred.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records in compliance with quality and regulatory requirements.
• Perform operations in a cleanroom environment with aseptic processing controls, gowning and cleaning procedures.
• Document tasks in manufacturing records and logbooks following GDP guidelines.
• Maintain and operate equipment per SOPs and qualifications.
• Ensure materials are issued and accounted for during execution of records.
• Apply and demonstrate understanding of cGMP in daily tasks and responsibilities.
• Participate in workplace organization and team collaboration.

Skills

Upstream processing knowledge

GxP compliance

Team collaboration

Education

Bachelor’s degree in a scientific or engineering discipline

High school diploma with 4-6 years of related experience

Tools

Single-use platform technology

Job description

Position Summary

This position operates on a night shift 2-2-3 schedule. The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). As needed, the Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment.

The Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest). The Manufacturing Associate will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Following task execution, the Manufacturing Associate will review the executed production records and logbooks to ensure GxP compliance.

The Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. Staff will work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant. A proven Manufacturing Associate will demonstrate the following qualities: learning agility, orientation toward action, results driven, team player, strong attention to detail, and superior integrity and accountability.

Position Responsibilities

• Manufacture bulk intermediates and drug substances per manufacturing batch records in compliance with quality, company policies, and current regulations
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing, including gowning and cleaning procedures
• Document each task involving manufacturing records and logbooks following GDP at the time of execution
• Utilize and perform maintenance on equipment per applicable SOP
• Ensure all materials are issued and accounted for during the execution of a record
• Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities
• Participate and be accountable for workplace organization

Position Requirements

• 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 diploma and 4-6 years’ experience, or equivalent
• Basic knowledge of upstream processing- cell culture or fermentation
• Experience in single-use platform technology is preferred

*Please note: this is a night shift opportunity and will be eligible for a shift differential on top of listed salary*

Salary Range: $24-$31.25/hour

• 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

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, 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.