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2 дня назад

Director, Bioprocess / Process Development – Pivotal Drug Substance (Biopharmaceutical Process Development)

184 494 - 249 610$
Формат работы
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, Bioprocess / Process Development – Pivotal Drug Substance (Biopharmaceutical Process Development): Leading development, characterization, scale-up, and commercialization support for drug substance cell culture and purification processes with an accent on late-stage biologics, regulatory filings, and multi-site scientific leadership. Focus on integrating cell culture and purification, transferring processes to manufacturing, deploying innovative bioprocess technologies, and leading a 30+ person organization.

Location: Cambridge, Massachusetts, or Thousand Oaks, California, United States

Annual salary: $184,494.20–$249,609.80 USD

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

  • Lead a multi-site, multifunctional drug substance organization integrating cell culture and purification disciplines.
  • Manage and develop a team of more than 30 scientists and engineers, including recruitment, retention, portfolio prioritization, and resource allocation.
  • Advance commercial process development, process characterization, lifecycle management, and control strategy development for biologics.
  • Partner with engineering, manufacturing, and external collaborators to support process transfer and commercialization.
  • Author and review global regulatory filings and respond to regulatory agency questions.
  • Drive innovative bioprocess technologies, automation, digital strategies, publications, patents, and external scientific engagement.

Requirements

  • Doctorate degree with 4 years of scientific process development experience, or master’s degree with 8 years, or bachelor’s degree with 10 years.
  • At least 4 years of direct people management or leadership experience involving teams, projects, programs, or resource allocation.
  • Experience in biopharmaceutical process development, including late-stage biologics development, process design, characterization, validation, and regulatory interactions.
  • Deep expertise in cell culture bioreactor processes or downstream purification processes.
  • Ability to provide scientific and engineering leadership on complex cross-functional programs.
  • Experience with statistical data analysis, technical decision-making, senior-level communication, and talent development.

Nice to have

  • PhD in biochemistry, biochemical engineering, chemical engineering, or a related discipline.
  • 10 or more years of biopharmaceutical process development experience.
  • Active engagement in the scientific community through publications, patents, or industry forums.

Culture & Benefits

  • Collaborative, innovative, and science-based work environment.
  • Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
  • Retirement and savings plan with company contributions.
  • Annual bonus program, stock-based long-term incentives, and award-winning time-off plans.
  • Career development opportunities and flexible work models where applicable.

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