17 часов назад
Associate Manufacturing (Biotechnology)
70 985 - 96 038$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Manufacturing (Biotechnology): Performing hands-on manufacturing operations at a biotech drug substance plant with an accent on GMP compliance, process monitoring, validation, clean-room operations, and analytical testing. Focus on troubleshooting production equipment, preparing buffers and media, maintaining quality records, and implementing continuous improvements across manufacturing processes.
Location: Onsite in Thousand Oaks, California, United States. Must work in a clean room environment and be available for varied shifts, including weekends, holidays, and 8-, 10-, or 12-hour schedules.
Annual salary: USD 70,985.20–96,038.80.
Company
is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Perform and monitor manufacturing operations, including setup, cleaning, sanitization, media and buffer preparation, and analytical testing.
- Support development, clinical, and launch activities at the Thousand Oaks drug substance plant.
- Execute validation protocols and comply with GMP, safety, and regulatory requirements.
- Draft and revise manufacturing plans, SOPs, technical reports, batch records, and other documentation.
- Own quality records such as CAPA and CAPA-EV, support audits, and identify process improvements.
- Troubleshoot production equipment, direct and train operators, support new technology implementation, and participate in cross-functional teams.
Requirements
- High school diploma or GED plus 2 years of manufacturing or operations experience; or an associate degree plus 6 months of experience; or a bachelor's degree.
- Ability to work onsite in a clean room while wearing full gowning, gloves, hairnet, and steel-toe shoes.
- Availability for day, swing, and overnight shifts, including weekends and holidays.
- Ability to perform rigorous and repetitive work around high-pressure systems and occasionally heavy equipment.
- Understanding of GMP documentation, safety, compliance, and basic troubleshooting.
- Sponsorship for this role is not guaranteed.
Nice to have
- Bachelor's degree in science or engineering.
- Knowledge of purification, cell culture, aseptic processing, single-use systems, CFR, and regulatory requirements.
- Experience with Delta V, laboratory equipment, analytical methods, technical writing, project management, or presentations.
- Mechanical aptitude and basic chemistry, biology, physical science, statistical, and mathematical skills.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time off and career development opportunities.
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