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12 дней назад

Associate Manufacturing - Bulk Drug Substance Upstream - Days (Biotechnology)

Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
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TL;DR
Associate Manufacturing - Bulk Drug Substance Upstream - Days (Biotechnology): Supporting cell culture manufacturing operations, facility startup, technology transfer, and operational readiness at a new drug substance manufacturing facility with an accent on cGMP compliance, aseptic processing, and equipment operation. Focus on commissioning and qualification, executing manufacturing procedures, completing electronic batch records, and transitioning startup activities into 24/7 production.

Location: Holly Springs, North Carolina, United States. Onsite manufacturing role requiring Monday–Friday work during startup and a 12-hour 2-2-3 schedule during 24/7 operations, including holidays, overtime, and work during inclement weather when required.

Salary: Annual salary range for this role in the United States, excluding Puerto Rico; the exact range is not specified.

Company

hirify.global 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 cell culture manufacturing operations, including seed train, SUBs, perfusion, RTF, stainless-steel BRXs, depth filtration, and centrifugation.
  • 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 degree plus 6 months of relevant experience; or a bachelor’s degree.
  • Ability to follow cGMP procedures, SOPs, manufacturing procedures, job hazard analyses, and applicable regulations.
  • Ability to consistently follow gowning and aseptic techniques.
  • Ability to work effectively in a team-based manufacturing environment and support assigned shifts.
  • Strong verbal and written communication skills and willingness to learn and develop manufacturing skills.

Nice to have

  • NC BioWork or BioWorks Certification Program completion.
  • Biotechnology or pharmaceutical manufacturing experience.
  • Familiarity with EBR/MES, DeltaV, and electronic quality systems.
  • Basic understanding of cGMP manufacturing environments.

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 plans and company-wide shutdowns.
  • Career development opportunities and flexible work models where applicable.

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