KBI: US - Senior Manufacturing Associate II

KBI Biopharma, Inc.; Durham (NC); Hybrid; USD 65,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II (Nights) to perform upstream or downstream bioprocessing of bulk intermediates and drug substances in a cGMP facility.

You will follow approved procedures, write CAPAs, and support qualification of new equipment, working with QA and MS&T teams. The role requires experience in upstream or downstream operations, strong documentation, and clear communication, with a rotating 2‑2‑3 night schedule and a focus on right‑first‑time

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ GMP manufacturing operations experience.
• High school diploma with 7-10 years’ GMP manufacturing operations experience.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records and quality standards.
• Operate in a cleanroom environment and follow aseptic processing controls.
• Document tasks in manufacturing records and logs per GDP guidelines.
• Perform maintenance on production equipment according to SOPs.
• Ensure materials are issued and accounted for during record execution.
• Demonstrate understanding of cGMP and related tasks.
• Provide guidance to Manufacturing Associates and assist supervisor with workload distribution.

Skills

GMP compliance

SOP development

CAPA writing

Communication skills

English proficiency

Education

Bachelor's degree in related scientific or engineering discipline

High school diploma with GMP experience

Tools

ERP

MS Office

EDMS

Job description

Nightshift: 6PM-6AM, 2-2-3 rotating schedule The Senior Manufacturing Associate I/II (Nights) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Sr. 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 Sr. 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 Sr. Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), downstream unit operations (chromatography, tangential flow filtration, viral inactivation, and bulk filling) and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. The Sr. Manufacturing Associate will have past experience and a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). 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). The Sr. Manufacturing Associate will use past experiences and knowledge to teach, troubleshoot and continuously improve the daily operations of upstream or downstream manufacturing. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. The Sr. Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP with minimal supervision and effectively communicate with the manufacturing supervisor and support groups. 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. The Sr. Manufacturing Associate will also be expected to review the manufacturing schedule, executed manufacturing documentation, and ERP orders to ensure compliant operations and schedule adherence. Staff will effectively communicate questions, concerns, or deviations to management and the quality system according to KBI internal notification processes.

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).

Provide direction/guidance to Manufacturing Associates.

Help supervisor to distribute the workload and ensure others understand the requirements of their tasks.

MINIMUM REQUIREMENTS

• Sr. Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ experience in related GMP manufacturing operations; or high school degree with 7-10 years’ experience in related GMP manufacturing operations.
• Sr. Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ experience in related GMP manufacturing operations; or high school degree with 10+ years’ experience in related GMP manufacturing operations.
• Basic knowledge of upstream (cell culture or fermentation) or downstream (purification and bulk filling) 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.
• 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 Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, 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.

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.