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Full-time
high school, associate degree, bachelor degree
Posted 25d ago
~40 hrs/week
Responsibilities
The Manufacturing Associate is responsible for executing purification and cell culture production activities within a GMP environment. They must document all tasks according to GDP and ensure compliance with quality standards and aseptic processing controls.
Requirements
Candidates must have a high school diploma and experience in a regulated industry or knowledge of downstream unit operations. The role requires the ability to work a 12-hour rotating shift, including weekends, nights, and holidays.
Full job description
*Dayshift: 6AM-6PM, 2-2-3 rotating schedule
This position is on a 2-2-3 shift, 6a-6p. The Manufacturing Associate I/II – Downstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment.
The Manufacturing Associate I/II – Downstream 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). Downstream is responsible for the execution of purification activities for early and late-phase Cell Culture programs within a GMP environment.
The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to cell culture clarification, chromatography operations using the Cytiva UNICORN software application, viral inactivation, ultrafiltration/diafiltration systems, various other filtration techniques utilizing single use technologies. Various analytical tools (SoloVPE, pH/Conductivity meters) and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, scales) are used on a daily basis. Following task execution, the Manufacturing Associate I/II will review the executed production records (SR’s, ERP, and BR’s) to ensure GxP compliance.
Position Responsibilities:
Purification of cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. The duties required include, but are not limited to, purification processing using various chromatography, filtration, and viral reduction techniques up through bulk fill of drug product/intermediate.
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 materials/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’s.
Requirements:
High school diploma.
Experience in a regulated industry or demonstrated knowledge of downstream or purification unit operations.
Ability to follow written instructions.
Excellent written and verbal communication skills.
Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
Energetic, motivated and dynamic individual.
Must have high attention to detail.
Ability to work a 12-hour schedule to include weekends, nights and Holidays.
Preferred Qualifications:
Associates or Bachelor’s degree in a related scientific or engineering discipline
Biowork certification.
Experience in single-use platform technology.
Experience in a CDMO.
About KBI:
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.
KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
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.
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.
With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs.
KBI is proud to be a JSR Life Sciences Company.
Offices: 4117 Emperor Blvd, Durham, North Carolina 27703, US · 1101 Hamlin Rd., Durham, NC 27704, US · 2500 Central Ave., Boulder, CO 80301, US · 1450 Infinite Drive., Louisville, CO 80027, US · 47 National Way, Durham, North Carolina 27703, US
How much do Science & Research jobs in Durham, NC pay?
Based on 414 listings with disclosed salaries, most science & research jobs in Durham, NC pay between $55k–$221k per year. Individual offers vary with seniority, company size, and specialization.
How many Science & Research jobs are open in Durham, NC right now?
There are currently 978 open science & research positions in Durham, NC listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Durham, NC?
Companies currently hiring include Duke University School of Medicine, Duke University Hospital, IQVIA, Duke Health Technology Solutions, KBI Biopharma, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Durham, NC?
Yes — 207 of the 978 open science & research positions offer remote or hybrid work (100 remote, 107 hybrid).
How do I apply for Science & Research jobs in Durham, NC?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.