Manufacturing Associate I/II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC is seeking a Manufacturing Associate I/II to perform upstream or downstream production activities for cell culture programs in a GMP environment.

You will execute tasks per SOPs, batch records and GDP/GLP standards while maintaining cleanroom controls and thorough documentation. The role emphasizes basic cell culture/fermentation/purification operations knowledge, strong communication skills, and the ability to work in a fast-paced setting with a positive,

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline; GMP manufacturing experience preferred.
• Basic understanding of cell culture, fermentation or purification unit operations; single-use platform experience preferred.
• Strong written and verbal communication skills; able to work in fast-paced environment.

Responsibilities

• Manufacture cell culture products per batch records while complying with quality standards and regulations.
• Perform cleanroom operations and aseptic processing controls, including gowning and cleaning procedures.
• Document manufacturing procedures (SRs, EPRs, BRs) per GDP practices at the time of execution.
• Ensure issuance and accountability of items used in manufacturing records (SR, EPR, BR).
• Demonstrate knowledge of cGMP in daily tasks and maintain 5S standards.

Skills

Cell culture

Fermentation

Purification

Single-use platform

Documentation

Education

Bachelor's degree in a related scientific or engineering discipline

Tools

MS Office

ERP

EDMS

Job description

Job Summary

Job Description Day Shift / 7AM -7PM / 2-2-3 schedule The Manufacturing Associate I/II will perform Upstream or 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.
• 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.

Minimum Requirements

• Manufacturing Associate 1: 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.

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 ladder may be required when setting up bioreactors.

Computer Skills

MS Office, ERP, EDMS, production equipment software, other.

Equipment Use Examples

• Biosafety Cabinets
• Incubators
• Single Use Bioreactors
• Chromatography Columns/Skids
• Ultrafiltration Skids
• Filling systems
• Peristaltic Pumps and Other Single Use pumps
• Automated Cell Counters
• Blood Gas Analyzers
• Metabolite Analyzers
• Scales and Balances
• pH and Osmolality meters
• other lab, production, and office equipment

Working Conditions

• 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.

Essential Physical Functions

• Staff will stand throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks.
• Staff will walk throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks.
• Staff will perform activities such as training, document review, and other computer work, as required.
• Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed.
• Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed.
• Staff must perform some operations on ladders or step stools.
• Staff must be able to reach underneath production equipment for bioprocess container installation and inspection.
• Staff must be able to reach underneath, over, and within production equipment for bioprocess container installation, inspection and use.
• Staff must be fluent in English language.
• Staff must be able to speak with other staff over radios, cell phones, and within production locations over machine noise.
• Staff will read production instructions to others and appropriately understand instructions.
• Staff must be able to hear other staff over radios, cell phones, and within production locations over machine noise.
• Staff will listen to other staff during reading of production instructions and appropriately understand instructions.
• Staff must be able to read manufacturing procedures and execute production activities.

EEO / Diversity Statement

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

Employer Branding

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.