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21 час назад

Front Line Manufacturing Manager (Biologics)

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
Front Line Manufacturing Manager (Biologics): Leading downstream bulk drug substance manufacturing operations during the startup and ramp-up of a new biologics facility with an accent on facility readiness, cGMP execution, and technology transfer. Focus on commissioning and qualification, process implementation, team leadership, and resolving operational issues across 24/7 manufacturing shifts.

Location: Holly Springs, North Carolina, United States. The role begins with a Monday–Friday, 8:00 a.m.–5:00 p.m. startup schedule and transitions to a 12-hour 2-2-3 day-shift schedule from 5:45 a.m. to 6:15 p.m. supporting 24/7 manufacturing operations. Nonstandard hours, holidays, inclement-weather shifts, and overtime may be required.

Company

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

What you will do

  • Lead, develop, and coach a downstream manufacturing team while establishing expectations for safety, quality, and accountability.
  • Support the design, build, commissioning, qualification, staffing, training, and operational readiness of a new manufacturing facility.
  • Oversee cGMP-compliant downstream purification operations, including column packing, chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill.
  • Support technology transfer and process implementation, including manufacturability, troubleshooting, and continuous improvement.
  • Partner with Quality, Engineering, NPI, Supply Chain, Validation, and site leadership during startup and manufacturing ramp-up.
  • Maintain inspection readiness and drive improvements in operational efficiency, reliability, and scalability.

Requirements

  • Doctorate; or a master’s degree with 3 years of manufacturing or operations experience; or a bachelor’s degree with 5 years; or an associate degree with 10 years; or a high school diploma/GED with 12 years.
  • Previous managerial experience directly managing people or experience leading teams, projects, programs, or resource allocation.
  • Ability to work assigned 12-hour shifts, including nonstandard hours, some holidays, inclement weather, and requested overtime.
  • Experience with manufacturing operations, safety and quality standards, and regulatory requirements.
  • Preferred experience with facility startup, commissioning, operational readiness, biologics or downstream drug substance manufacturing, cGMP, technology transfer, and process implementation.
  • Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems is preferred.

Culture & Benefits

  • Health, dental, vision, life, disability, and flexible spending benefits for employees and eligible dependents.
  • Retirement and savings plan with company contributions.
  • Discretionary annual bonus program and stock-based long-term incentives.
  • Paid time-off plans and biannual company-wide shutdowns.
  • Career development opportunities and flexible work models where applicable.

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