11 дней 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) (Downstream Drug Substance Manufacturing): Supporting startup, operational readiness, and routine manufacturing operations for a new biologics drug substance facility with an accent on cGMP compliance, downstream purification, and equipment operation. Focus on executing column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill processes while supporting commissioning, qualification, technology transfer, and continuous improvement.
Location: Holly Springs, North Carolina, United States; onsite manufacturing role requiring Monday–Friday startup hours and later a 12-hour 2-2-3 schedule from 5:45am to 6:15pm, including holidays, inclement weather, and requested overtime as needed.
Annual salary: $70,985.20–$96,038.80 USD
Company
is a biotechnology company developing treatments and operating advanced drug substance manufacturing facilities.
What you will do
- Support facility expansion, operational readiness, commissioning, qualification, and startup execution.
- Perform downstream purification operations, including column packing, column 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.
- Document deviations and quality events, support investigations and corrective actions, and escalate operational issues.
- Transition from startup activities to routine manufacturing execution and continuous improvement.
Requirements
- High school diploma or GED plus 2 years of manufacturing or regulated-environment experience; or an associate’s degree plus 6 months of relevant experience; or a bachelor’s degree.
- Knowledge of cGMP practices, SOPs, manufacturing procedures, and aseptic techniques.
- Ability to work assigned 12-hour shifts, including holidays, inclement weather, and overtime when required.
- Ability to work effectively in a team-based manufacturing environment with strong verbal and written communication.
- Proficiency with Microsoft Office and electronic systems such as EBR/MES, DeltaV, and electronic quality systems.
Nice to have
- NC BioWorks Certification Program completion.
- Experience in biotechnology, pharmaceuticals, or another regulated industry.
- Process experience in a cGMP manufacturing facility.
Culture & Benefits
- 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 biannual company-wide shutdowns.
- Career development opportunities and flexible work models where applicable.
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