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Director, Manufacturing (Bioconjugate Manufacturing)

198 900 - 232 050$
Формат работы
remote (только USA)/onsite
Тип работы
fulltime
Грейд
director
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
Director, Manufacturing (Bioconjugate Manufacturing): Developing and executing operational readiness for a U.S. growth investment project supporting bioconjugate drug substance manufacturing with an accent on GMP compliance, facility start-up, validation, and manufacturing organization design. Focus on integrating operational requirements across facility design and commissioning, leading technology transfer and commercial launch readiness, and building a high-performing manufacturing organization.

Location: Currently remote in the United States; transition to an on-site East Coast or Midwest U.S. location is anticipated as the project progresses, with an expected timeline in 2027. Monday–Friday, 8:00 a.m. to 5:00 p.m.; domestic and international travel of approximately 25–30% required.

Salary: $198,900–$232,050 base annual salary, plus performance-related bonus and benefits.

Company

hirify.global operates globally connected manufacturing and life sciences sites supporting the development and production of medicines.

What you will do

  • Lead operational readiness for a U.S. growth investment project from facility design and construction through commissioning, qualification, validation, start-up, and operational handover.
  • Develop the operations readiness roadmap covering organizational design, workforce planning, training, process readiness, validation support, and transition to routine GMP manufacturing.
  • Define the future manufacturing organization, including staffing plans, shift structures, governance, interfaces, and operational ownership.
  • Represent Operations in facility and process design reviews, integrating manufacturing requirements into equipment, automation, process flow, and facility decisions.
  • Partner with Engineering, Quality, MSAT, Automation, EHS, HR, Finance, and project leadership to manage risks and prepare for technology transfers, customer onboarding, and commercial launch.
  • Build and lead a manufacturing organization focused on safety, quality, accountability, continuous improvement, inspection readiness, and long-term reliability.

Requirements

  • Master’s degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related field preferred; a bachelor’s degree with significant relevant experience may be considered.
  • 12+ years of leadership experience in pharmaceutical, biotechnology, biologics, or bioconjugate manufacturing.
  • Experience leading manufacturing operations in a CDMO environment, including customer interactions, technology transfers, operational planning, and multiple client programs.
  • Experience with bioconjugate drug substance manufacturing, scale-up, validation, technology transfer, start-up, commercial manufacturing, and major capital or facility investment projects.
  • Strong knowledge of GMP operations, regulatory requirements, process validation, commissioning, qualification, operational readiness, inspection preparedness, and risk mitigation.
  • Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve; willingness to travel domestically and internationally up to approximately 25–30%.

Nice to have

  • Knowledge of Lean Manufacturing, Six Sigma, automation systems, digital manufacturing platforms, and data integrity principles.
  • Master’s degree in a relevant engineering, biotechnology, life sciences, or pharmaceutical discipline.

Culture & Benefits

  • Medical, dental, and vision insurance.
  • 401(k) matching plan.
  • Life insurance and short- and long-term disability insurance.
  • Employee assistance programs and paid time off.
  • Performance-related bonus.
  • Work with globally connected teams across more than 30 sites and five continents.

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