KBI: US - Senior Manufacturing Associate I / ll (Nights)

KBI Biopharma, Inc.; Durham (NC); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II (Nights) to perform upstream or downstream bioprocessing and support operations. You will follow GMP/GLP, maintain documentation, and write SOPs/MBRs while ensuring Right First Time output.

The role requires knowledge of bioprocessing equipment, strong English communication, and the ability to work in a fast-paced 12-hour night shift. Cleanroom, cGMP, and safety compliance are essential.

Formación

• Bachelor’s degree in a related scientific or engineering discipline with 4–6 years’ GMP manufacturing operations experience or high school with 7–10 years’ GMP ops experience.
• Bachelor’s degree with 5+ years’ GMP ops experience or high school with 10+ years’ GMP ops experience.
• Knowledge of upstream (cell culture/fermentation) or downstream (purification/bulk filling) operations preferred.
• Excellent written and verbal communication skills are required.
• Strong problem solving and mathematical reasoning abilities are essential.

Responsabilidades

• Manufacture bulk intermediates and drug substances per batch records and quality standards.
• Operate in a cleanroom environment with aseptic processing controls.
• Document all manufacturing tasks in records and logbooks per GDP.
• Maintain and troubleshoot equipment per SOPs.
• Ensure materials are issued and accounted for during records execution.
• Demonstrate understanding of cGMP per task and responsibility.
• Participate in workplace organization (5S) and provide guidance to Manufacturing Associates.
• Assist supervisor to distribute workload and clarify task requirements.

Conocimientos

Upstream processing

Downstream processing

Single-use platforms

Communication skills

Problem solving

Math skills

English proficiency

Educación

Bachelor’s degree in related science/engineering

High school diploma with GMP experience

Herramientas

MS Office

ERP

EDMS

Production equipment software

Descripción del empleo

JOB SUMMARY

Nightshift: 7PM-7AM, 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.

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.