Manufacturing Associate I/II- Upstream

KBI Biopharma, Inc.; Durham (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Manufacturing Associate I/II to perform upstream processing for biopharmaceutical products.

On a 2-2-3 rotating schedule (dayshift, 7am-7pm), you will follow approved procedures to ensure Right First Time production, maintain strict GMP/GLP documentation, and support SOPs/MBRs. You will work with QA, MS&T, facilities, and other departments to ensure reliable, compliant operations.

Qualifications

• Excellent written and verbal communication skills required.
• Fluent in reading and writing English.
• Ability to read and interpret safety rules and batch records.
• Ability to write routine reports and correspondence.
• Ability to speak effectively to groups.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records in compliance with quality standards.
• Perform operations in a cleanroom environment with aseptic processing controls.
• Document tasks in manufacturing records and logbooks following GDP.
• Utilize and perform maintenance on equipment per applicable SOP.
• Demonstrate understanding of cGMP in assigned tasks and participate in 5S.

Skills

Communication skills

Reading/writing English

Numerical ability

Reasoning ability

Mathematical calculations

Education

Bachelor’s degree in a scientific or engineering discipline

High school diploma

Job description

JOB SUMMARY

This position is on a 2-2-3 rotating schedule, dayshift (7am-7pm) The Manufacturing Associate I/II is responsible for performing upstream processing 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.

JOB RESPONSIBILITIES

Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, 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 (i.e. SR, EPR and BR). Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities. Participate and be accountable for workplace organization (5S).

MINIMUM REQUIREMENTS

• Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline and 0-2 years’ experience in related cGMP manufacturing operations; or high school degree and 3-5 years’ experience, or equivalent.


• 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 degree and 4-6 years’ experience, or equivalent.


• All Levels: Basic knowledge of upstream (cell culture or fermentation) 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.


• Language Ability Fluent in reading and writing the English language.


• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch production records.


• Ability to write routine reports and correspondence.


• Ability to speak effectively to groups.


• 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.

WORKING CONDITIONS

Are there particular working conditions associated with this position that should be noted (i.e., working environment, hours of work, travel, workspace, etc.)? Yes 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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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.