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2 часа назад

Director, Process & Analytical Development (Biotechnology)

196 700 - 232 650$
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, Process & Analytical Development (Biotechnology): Leading analytical development, process development, and project-specific manufacturing activities for a U.S. life sciences organization with an accent on GMP compliance, technology transfer, operational readiness, and commercialization. Focus on building and scaling the ADPD organization, supporting facility startup and expansion, managing strategic portfolios and budgets, and driving Lean transformation across manufacturing operations.

Location: Initially 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. Travel to EMEA and North America is required approximately 25–30% of the time.

Salary: $196,700–$232,650 gross annual base salary, plus a performance-related bonus.

Company

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

What you will do

  • Lead, coach, and develop the analytical development, process development, and project-specific manufacturing organization.
  • Define strategic direction through long-term planning, portfolio management, resource allocation, organizational design, and performance management.
  • Oversee development and manufacturing execution against safety, quality, compliance, delivery, and cost objectives.
  • Establish capabilities, infrastructure, governance, metrics, and talent needed for future manufacturing operations and business growth.
  • Partner with R&D, Manufacturing, MSAT, Engineering, Quality, Automation, Supply Chain, and Commercial teams on technology transfer, operational readiness, and commercialization.
  • Support site startup, facility expansion, validation, capital investments, and strategic transformation initiatives.

Requirements

  • Master’s degree in engineering, life sciences, chemistry, pharmaceutical sciences, or a related field; PhD preferred.
  • 15+ years of progressive leadership experience in pharmaceutical, biotechnology, CDMO, or related life sciences environments.
  • Extensive experience in process development, analytical development, technical operations, manufacturing, or other GMP-regulated organizations.
  • Deep knowledge of small molecule and bioconjugate technologies, pharmaceutical manufacturing, cGMP, technology transfer, validation, operational readiness, and commercialization.
  • Experience with facility startup, expansion projects, greenfield or brownfield investments, large-scale capital programs, organizational growth, and operational scale-up.
  • Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve, with approximately 25–30% travel to EMEA and North America.

Nice to have

  • PhD in engineering, life sciences, chemistry, pharmaceutical sciences, or a related field.

Culture & Benefits

  • Performance-related bonus.
  • Medical, dental, and vision insurance.
  • 401(k) matching plan.
  • Life insurance, short-term and long-term disability insurance, and employee assistance programs.
  • Paid time off.

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