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6 дней назад

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

106 148 - 143 612$
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 - Upstream) - Night Shift (Biotechnology): Leading night-shift upstream GMP drug substance manufacturing operations and experienced manufacturing associates at Amgen’s advanced biotech facility with an accent on safety, compliance, team development, and continuous improvement. Focus on supervising floor operations, optimizing regulated manufacturing processes, resolving complex CAPA-related issues, and coordinating with Quality, Engineering, Regulatory, and Process Development teams.

Location: On site in Holly Springs, North Carolina, United States. Night shift follows a 2-2-3, 12-hour rotation from 5:45 PM to 6:15 AM.

Salary: $106,148–$143,612 per year.

Company

hirify.global is a biotechnology company developing medicines and operating an advanced drug substance manufacturing facility using disposable technologies, stainless-steel equipment, industry 4.0 capabilities, and sustainability initiatives.

What you will do

  • Lead on-shift floor operations and experienced manufacturing associates producing GMP drug substance.
  • Maintain a safe, compliant production environment and ensure adherence to cGMP, CFR, gowning, and aseptic requirements.
  • Supervise, coach, hire, train, evaluate, and develop manufacturing staff while driving team performance.
  • Oversee critical manufacturing processes, equipment setup, execution, completion, production schedules, and maintenance activities.
  • Identify and implement process improvements, CAPAs, change controls, and solutions to complex operational problems.
  • Collaborate with QA/QC, Facilities and Engineering, PPIC, Manufacturing, Process Development, and Regulatory teams.

Requirements

  • Doctorate degree; or a master’s degree plus 3 years of manufacturing or operations experience; or a bachelor’s degree plus 5 years; or an associate degree plus 10 years; or a high school diploma/GED plus 12 years.
  • Previous experience directly managing people or leading teams, projects, programs, or resource allocation.
  • Experience in manufacturing or operations, preferably in biotechnology, pharmaceuticals, or a highly regulated cGMP environment.
  • Strong leadership, coaching, mentoring, conflict resolution, analytical problem-solving, project management, and technical communication skills.
  • Working knowledge of manufacturing processes, regulatory requirements, Microsoft tools, EBR/MES, Delta V, and electronic quality systems.

Nice to have

  • Bachelor’s degree in life sciences or engineering.
  • Experience with biotechnology or pharmaceutical plant startup and upstream or downstream operations.
  • Five years of process experience in a cGMP manufacturing facility.
  • Three or more years in a production Area Lead, Specialist, or Manager role.

Culture & Benefits

  • Career-development resources to expand skills and expertise.
  • Diverse and inclusive workplace where employees are encouraged to contribute ideas.
  • Total rewards package covering health, financial, work-life balance, and career benefits.
  • Full-time employment with a structured night-shift schedule.

Hiring process

  • Applicants can complete a Workday Career Profile and upload an updated resume or work history.
  • Internal applicants must generally have been in their current position for at least 18 months and meet performance eligibility requirements.

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