KBI: US - Manufacturing Associate I/II

KBI Biopharma, Inc.; North Carolina; Vor Ort; USD 55.000 - 72.000; Vollzeit

Zusammenfassung

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to execute upstream or downstream production activities in a GMP environment.

You will work across media preparation, bioreactor setup, cell culture harvest, aseptic technique, chromatography, and fill operations, ensuring adherence to cGMP, GDP, and GLP with a strong ownership mindset. The role requires following SR’s, EPR’s, BR’s and SOPs, while maintaining accurate production records and contributing to a safe, compliant

Qualifikationen

• Bachelor’s degree in a related scientific or engineering discipline with GMP exposure.
• Experience in GMP manufacturing operations or related field preferred.
• Strong written and verbal communication in English.

Aufgaben

• Manufacture cell culture products per batch records in compliance with quality standards.
• Perform aseptic operations in a cleanroom including gowning and cleaning procedures.
• Document tasks following GDP and record-keeping standards.
• Ensure items are issued and accounted for during execution of records.
• Apply understanding of cGMP and participate in room 5S and equipment maintenance.

Kenntnisse

GMP knowledge

GDP

GLP

Aseptic processing

English fluency

Ausbildung

Bachelor’s degree in a related scientific or engineering discipline

Tools

Single Use Bioreactors

Chromatography

Ultrafiltration

Filling systems

Pumps and meters

Jobbeschreibung

JOB SUMMARY

*12 hours, 7AM-7PM, 2*2*3 The Manufacturing Associate I/II is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. The Manufacturing Associate I/II must follow the instructions depicted in SR’s, EPR’s, BR’s, SOP’s and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time’ (RFT). The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to various unit operations including media/buffer preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, aseptic technique, chromatography, ultrafiltration, and drug substance filling operations; as well as to analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolality meters). Following task execution, the Manufacturing Associate I/II will review the executed production records (SR’s, ERP, and BR’s) to ensure GxP compliance.

JOB RESPONSIBILITIES

• Manufacture cell culture products per manufacturing batch records 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 procedures (i.e. SR’s, EPR’s and BR’s) following GDP at the time of execution.
• Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
• Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities.
• Participate and be accountable for room 5S.
• Utilize and perform maintenance on equipment per applicable SOP.

MINIMUM REQUIREMENTS

• Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline with 0-2 years’ experience in related GMP manufacturing operations; or high school diploma with 3-5 years’ experience in related GMP manufacturing operations. Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 2-5 years’ experience in related GMP manufacturing operations; or high school diploma with 4-6 years’ experience in related GMP manufacturing operations. 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 face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. 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. 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. 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. 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.

EEO / DEI STATEMENTS

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.

APPLICATION ACKNOWLEDGMENT

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.

COMPANY CULTURE

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.

TOOLS & EQUIPMENT

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

RECRUITMENT POLICY

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.