13 дней назад
Associate Manufacturing (Bulk Drug Substance Downstream, Days)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Manufacturing (Bulk Drug Substance Downstream, Days) (Biomanufacturing/cGMP): Supporting downstream purification operations, facility startup, technology transfer, and manufacturing readiness for a new drug substance facility with an accent on chromatography, TFF, viral filtration, conjugation, and final fill. Focus on executing hands-on manufacturing, completing commissioning and qualification activities, maintaining aseptic and cGMP compliance, and supporting 24/7 operations on a 12-hour shift schedule.
Location: Holly Springs, North Carolina, United States; onsite manufacturing role with Monday–Friday startup hours followed by a 12-hour 2-2-3 shift schedule.
Company
is a biotechnology company developing treatments and operating advanced drug substance manufacturing facilities.
What you will do
- Support facility expansion, startup, operational readiness, and technology transfer activities.
- Perform downstream purification operations including column packing, chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill.
- Set up, operate, monitor, clean, and sanitize manufacturing equipment and assigned areas.
- Perform in-process sampling, operate analytical equipment, and complete Electronic Batch Records.
- Support commissioning, qualification, training, procedure execution, and continuous improvement.
- Document deviations and quality events, support investigations, and escalate safety, quality, and schedule issues.
Requirements
- High school diploma/GED plus 2 years of manufacturing or regulated-environment experience; or an associate degree plus 6 months of relevant experience; or a bachelor’s degree.
- Experience or understanding of cGMP manufacturing in a regulated industry such as biotechnology or pharmaceuticals.
- Ability to follow gowning, aseptic technique, SOP, safety, and compliance requirements.
- Ability to work assigned 12-hour shifts, including holidays, inclement weather, and requested overtime.
- Strong verbal and written communication, teamwork, and willingness to learn.
- Knowledge of Microsoft Office and electronic systems such as EBR/MES, DeltaV, and electronic quality systems.
Nice to have
- Completion of the NC BioWorks Certification Program.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus and stock-based long-term incentives.
- Paid time off plans and company-wide shutdowns.
- Career development opportunities and flexible work models where applicable.
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