Manufacturing Associate I/II

KBI Biopharma, Inc.; North Carolina; Presencial; USD 52 000 - 78 000; Tempo integral

Resumo da oferta

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II (Nights) to perform downstream production activities for cell culture programs in a GMP environment. You will follow SOPs and batch records, perform cleanroom operations, and document procedures per GDP/GMP standards, while maintaining 5S and quality controls.

The role requires basic knowledge of cell culture, fermentation, or purification operations and strong communication in a fast-paced, multitasking setting.

Qualificações

• Bachelor's degree in a related scientific or engineering discipline; GMP manufacturing experience preferred.
• Associate I: 0–2 years GMP experience; Associate II: 2–5 years GMP experience.
• Basic knowledge of cell culture, fermentation or purification unit operations preferred.
• Experience with single-use platform technology preferred.

Responsabilidades

• Manufacture cell culture products according to batch records while complying with quality standards and regulations.
• Perform cleanroom operations with aseptic processing controls and gowning procedures.
• Document procedures (SRs, EPRs, BRs) per GDP standards during execution.
• Ensure proper issuance and accountability of items used in records.
• Apply cGMP knowledge in daily tasks and maintain 5S cleanliness.
• Operate and maintain equipment per SOPs.

Descrição da oferta de emprego

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

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.

EEO/AA Statement

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.

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.

Company Culture & Values

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.

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.