7 дней назад
Manufacturing Associate I/II - Downstream (Biotech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manufacturing Associate I/II - Downstream (Biotech): Manufacturing cell culture products in a cGMP biotechnology facility with an accent on downstream unit operations, aseptic processing, batch documentation, and equipment operation. Focus on performing chromatography, ultrafiltration, cleanroom activities, and accurate execution of manufacturing records on a 12-hour schedule.
Location: USA - NC - Durham - Hamlin Rd; onsite in a cGMP manufacturing biotechnology facility
Employment type: Full time
Company
operates in biotechnology manufacturing and develops cell culture products through early- and late-phase manufacturing programs.
What you will do
- Manufacture cell culture products according to batch records, quality standards, company policies, and current regulations.
- Perform downstream and other production unit operations, including media and buffer preparation, chromatography, ultrafiltration, and drug substance filling.
- Carry out cleanroom operations, gowning, cleaning, and aseptic processing controls.
- Document manufacturing activities in SRs, EPRs, and BRs according to Good Documentation Practices.
- Operate and maintain manufacturing equipment according to applicable SOPs, while maintaining 5S standards and facility organization.
- Work 12-hour shifts, including possible overnight work, in a fast-paced manufacturing environment.
Requirements
- For Manufacturing Associate I: a bachelor's degree in a related scientific or engineering discipline with 0–2 years of GMP manufacturing experience, or a high school diploma with 3–5 years of related GMP manufacturing experience.
- For Manufacturing Associate II: a bachelor's degree in a related scientific or engineering discipline with 2–5 years of GMP manufacturing experience, or a high school diploma with 4–6 years of related GMP manufacturing experience.
- Basic knowledge of cell culture, fermentation, or purification unit operations.
- Strong written and verbal communication skills and the ability to interpret technical, safety, operating, and manufacturing documentation.
- Fluent English reading, writing, and speaking skills are required.
- Ability to work onsite in cleanroom areas, wear cleanroom attire, and meet physical demands including prolonged standing, lifting, pushing, pulling, and ladder use.
Nice to have
- Experience with single-use platform technology.
- Previous experience in cell culture, fermentation, or purification unit operations.
Culture & Benefits
- Work in a regulated cGMP biotechnology manufacturing environment.
- Follow structured SOPs, batch records, and quality systems.
- Maintain a clean, organized, and efficient production workspace through 5S standards.
- Work in an environment involving mechanical, chemical, electrical, noise, and slip or fall hazards.
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