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13 дней назад

Associate Manufacturing (Bulk Drug Substance Downstream, Days)

Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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