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8 дней назад

Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Night Shift

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Night Shift (Biotechnology/Manufacturing): Leading 24/7 GMP drug substance manufacturing operations and supervising manufacturing associates on a 12-hour night-shift rotation with an accent on downstream purification, aseptic processing, safety, and compliance. Focus on coaching teams, optimizing production procedures, implementing CAPAs, resolving complex operational problems, and driving continuous improvement in a new biotechnology facility.

Location: Holly Springs, North Carolina, United States. Onsite night shift with a 12-hour 2-2-3 schedule from 5:45 p.m. to 6:15 a.m.

Company

hirify.global is a biotechnology company developing and manufacturing medicines and operating an advanced drug substance manufacturing facility with disposable and stainless-steel technologies.

What you will do

  • Lead manufacturing teams supporting 24/7 GMP drug substance production.
  • Maintain a safe, compliant production environment, including cGMP, CFR, gowning, and aseptic technique requirements.
  • Oversee manufacturing processes, equipment setup, execution, completion, and maintenance activities.
  • Recruit, train, coach, evaluate, and mentor manufacturing associates.
  • Identify improvement opportunities, lead change efforts, and optimize operating procedures.
  • Develop CAPAs, resolve complex operational problems, and collaborate with QA/QC, facilities, planning, manufacturing, process development, and regulatory teams.

Requirements

  • Doctorate degree; or master's degree with 3 years of manufacturing or operations experience; or bachelor's degree with 5 years; or associate's degree with 10 years; or high school diploma/GED with 12 years.
  • Previous managerial experience directly managing people or leading teams, projects, programs, or resource allocation.
  • Leadership and technical understanding of biotechnology production operations.
  • Experience in a cGMP manufacturing facility, including 5+ years of process experience and 3+ years in an area lead, specialist, or manager role.
  • Understanding of downstream purification operations, including column chromatography, TFF, viral filtration, and viral inactivation.
  • Strong communication, analytical problem-solving, conflict-resolution, project-management, computer, Microsoft, EBR/MES, Delta V, and electronic quality systems skills.

Nice to have

  • Bachelor's degree in life sciences or engineering.
  • Experience with biotechnology or pharmaceutical plant startup.
  • Experience with performance management, performance reviews, coaching, mentoring, and counseling.

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

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