Manufacturing Associate I/II - Downstream (Nights)

KBI Biopharma, Inc.; North Carolina; On-site; USD 42,000 - 54,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II (Nights) to perform downstream production activities for cell culture programs in a GMP environment.

The role covers media preparation, bioreactor operations, chromatography, ultrafiltration, and filling, with emphasis on documentation and compliance with GDP/GLP standards. The candidate should have basic knowledge of cell culture or purification, strong communication, and the ability to work in a fast-paced, 12-hour night schedule,

Qualifications

• Minimum: Bachelor's in a related science/engineering with GMP manufacturing experience, or HS diploma with relevant GMP experience.
• Basic knowledge of cell culture, fermentation, or purification operations preferred.
• Experience with single-use platform technology preferred.
• Excellent written and verbal communication skills required.
• Must be organized and able to work in a fast-paced, multitasking environment.
• Fluency in English (reading and writing).

Responsibilities

• Manufacture cell culture products according to batch records while ensuring quality standards.
• Perform cleanroom operations with aseptic processing controls.
• Document manufacturing procedures in GDP-compliant records at the time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records.
• Apply cGMP knowledge in daily tasks.
• Maintain 5S standards in the manufacturing environment.
• Operate and maintain equipment per SOPs.

Skills

Communication skills

Fluent English

Reading & interpreting documents

Writing routine reports

Public speaking

Problem solving

Organized & multitasking

Education

Bachelor's degree in related scientific/engineering discipline

High school diploma with GMP experience

Tools

Single-use platform technology

GMP manufacturing equipment

Job description

Job Summary Job Description

7PM-7AM / 2*2*3 Manufacturing Schedule The Manufacturing Associate I/II (Nights) will perform Downstream production activities for early and late-phase Cell Culture programs in a GMP environment. Responsibilities include executing tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy. The role involves various unit operations such as media/buffer preparation, bioreactor operations, aseptic techniques, chromatography, ultrafiltration, and drug substance filling. Candidates must maintain process ownership, facility upkeep, and thorough documentation review to ensure compliance. The ideal candidate should have a basic understanding of cell culture, fermentation, or purification unit operations, with preference given to those experienced in single-use platform technology. Strong written and verbal communication skills are essential. The role requires an energetic, motivated, and dynamic individual who is highly organized and capable of maintaining efficiency and a positive demeanor in a fast-paced, multitasking environment.

Primary Responsibilities

• Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations.
• Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures.
• Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR).
• Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities.
• Maintain and uphold 5S standards in the manufacturing environment.
• Operate and perform maintenance on equipment per applicable Standard Operating Procedures.

Minimum Requirements

• Manufacturing Associate I: Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience.
• Manufacturing Associate II: Bachelor's degree in a related scientific or engineering discipline with 2-5 years of GMP manufacturing experience; OR high school diploma with 4-6 years of related GMP manufacturing experience.
• Basic knowledge of cell culture, fermentation or purification unit operations is preferred.
• Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills are required.
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
• Language Ability: Fluent in English language both reading and writing.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of employees of organization.
• Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to compute rate, ratio, and percent and to draw and interpret graphs.

Physical Demands: Standing and sitting for long periods of time may be required at times. Lifting, pushing, and pulling may be required for stocking and movement of equipment. The use of a ladder may be required when setting up bioreactors.

WORKING CONDITIONS

There are particular working conditions associated with this position that should be noted (i.e., working environment, hours of work, workspace, etc.) The job requires working 12-hour shifts which may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.

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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.

Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to [e-mail]. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.