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3 дня назад

Vice President, Technical Development (Biotech)

340 000 - 360 000$
Формат работы
hybrid
Тип работы
fulltime
Грейд
head
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
Vice President, Technical Development (Biotech): Leading upstream, downstream, and analytical development for clinical-stage biologics through late-stage clinical development with an accent on CMC strategy, tech transfer, scale-up, and regulatory readiness. Focus on managing CDMO partnerships, guiding multi-disciplinary technical teams, and building compliant manufacturing and analytical processes for IND, BLA, NDA, and other global submissions.

Location: South San Francisco, California, United States; on-site at least three days per week

Base salary: $340,000–$360,000 annually

Company

hirify.global is a clinical-stage biotechnology company developing therapies for genetically validated cardioendocrine disease targets, including severe hypertriglyceridemia and acromegaly.

What you will do

  • Provide strategic and operational leadership across upstream process development, downstream process development, and analytical development.
  • Lead technical development from IND-enabling work through late-stage clinical development, including process characterization, scale-up, technology transfer, and CMC readiness.
  • Coordinate CDMOs and external partners to deliver process, analytical, technical transfer, and regulatory work packages.
  • Develop integrated technical strategies, executable statements of work, portfolio plans, timelines, and investment recommendations.
  • Lead CMC input for INDs, BLAs, NDAs, and other global regulatory filings, including authoring and reviewing CMC sections.
  • Build, mentor, and retain high-performing technical development teams while overseeing budgets and cross-functional collaboration.

Requirements

  • BS, MS, or PhD in chemical engineering, pharmaceutical sciences, biochemistry, chemistry, or a related field; PhD is highly desirable.
  • 15–20 years of biotechnology or pharmaceutical industry experience.
  • Leadership experience across at least two of upstream process development, downstream process development, analytical development, or drug product/formulation development.
  • Successful experience advancing products from early development through late-stage clinical development.
  • Strong understanding of GMP regulations, CMC requirements, and regulatory submissions.
  • Experience managing CDMOs, external development partners, and multidisciplinary technical teams.

Nice to have

  • Drug product or formulation development experience.
  • Prior experience as a CMC team lead for a late-stage product.

Culture & Benefits

  • Hands-on, collaborative environment with direct involvement across organizational levels.
  • Full-time position with at least three days per week working on-site.
  • Up to 10% travel required, with occasional peak travel periods.
  • Opportunity to shape a growing technical development organization and clinical-stage pipeline.

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