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2 дня назад

Associate Director, External Development and Manufacturing, Drug Product (Pharmaceutical Manufacturing)

129 000 - 203 100$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Релокация
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
Associate Director, External Development and Manufacturing, Drug Product (Pharmaceutical Manufacturing): Leading formulation, device, process development, and clinical manufacturing activities through external providers with an accent on GMP compliance, vendor selection, and cross-functional project execution. Focus on managing complex development timelines, resolving manufacturing risks, and building external manufacturing strategies across oral solid dosage forms, biologics, vaccines, and specialty products.

Location: Hybrid; primary location in Rahway, New Jersey, United States. Domestic relocation is indicated. The role requires 10% travel and is available to United States, Canada, and Puerto Rico residents; visa sponsorship is not available.

Salary: $129,000–$203,100 per year, plus potential annual bonus and long-term incentive.

Company

hirify.global develops medicines through pharmaceutical sciences, device development, external development, and manufacturing operations.

What you will do

  • Lead formulation, device, process development, and current GMP drug product manufacturing activities at contract research and manufacturing organizations.
  • Plan and coordinate development and clinical manufacturing activities across oral solid dosage forms, biologics, vaccines, specialty products, and drug-device combinations.
  • Provide manufacturing, compliance, and execution expertise while managing project timelines, deliverables, risks, and issue resolution.
  • Develop requests for proposals, evaluate vendor responses, and recommend providers based on technical fit, safety, capacity, timing, geography, and clinical supply needs.
  • Build and maintain vendor relationships and support technology evaluations, confidentiality agreements, technical information exchange, and agreement scoping.
  • Collaborate with product development, Quality, Analytical, Procurement, and Global Clinical Supply functions to improve workflows and externalization strategy.

Requirements

  • B.S. with at least 8 years of relevant industrial experience, or M.S. with at least 6 years, or Ph.D. with at least 4 years in Chemical Engineering, Pharmaceutical Sciences, or a related engineering or scientific discipline.
  • Relevant experience in pharmaceutical development, clinical manufacturing, supply chain, or external manufacturing.
  • Experience with vendor management, project management, cross-functional collaboration, and independent execution of business deliverables.
  • Strong knowledge of GMP, regulatory expectations, manufacturing compliance, and drug product development.
  • Excellent communication, facilitation, and stakeholder engagement skills, including the ability to influence teams without direct authority.
  • Strategic thinking, business acumen, creativity, sound judgment, and the ability to navigate ambiguity and solve complex problems rigorously.
  • Knowledge of business process design, implementation, and improvement; clinical manufacturing and supplies management; clinical trial management; data analysis; pharmaceutical sciences; risk management; root cause analysis; and solid dosage forms.

Nice to have

  • Direct drug product manufacturing, specialized scientific, or device development experience.
  • Experience leading business process optimization, continuous improvement, or transformation initiatives.
  • Familiarity with SAP for material build and transactions.

Culture & Benefits

  • Hybrid work arrangement with regular collaboration across scientific and operational functions.
  • Medical, dental, vision, healthcare, and other insurance benefits for employees and families.
  • Retirement benefits, including a 401(k).
  • Paid holidays, vacation, compassionate leave, and sick days.
  • Inclusive environment that values diverse experiences, perspectives, skills, and backgrounds.

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