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6 дней назад

Associate Director (Engineering), Biologics External Manufacturing Technical Operations (Biologics)

142 400 - 224 100$
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
Associate Director (Engineering), Biologics External Manufacturing Technical Operations (Biologics): Leading technical operations for external biologics and vaccine manufacturing with an accent on technology transfers, partner oversight, validation strategies, and regulatory compliance. Focus on resolving complex manufacturing issues, managing partner risks, optimizing processes and capacity, and ensuring receiving-site and inspection readiness.

Location: USA - Pennsylvania - West Point; travel within the designated US region is required, with approximately 25–30% travel and flexibility for short-term partner assignments. The posting is for US, Canada, and Puerto Rico residents.

Salary: $142,400–$224,100 annually for the primary location, plus eligibility for an annual bonus and long-term incentive where applicable.

Company

hirify.global is a research-intensive biopharmaceutical company developing health solutions for the prevention and treatment of disease in people and animals.

What you will do

  • Serve as the primary technical contact for external manufacturing partners, internal manufacturing sites, and commercialization teams.
  • Lead technical transfer planning and execution, including receiving-site readiness, resource planning, and delivery within schedule and budget.
  • Provide technical oversight of partner processes, proposed configurations, standards compliance, process changes, deviations, and Master Batch Record updates.
  • Lead partner technical due diligence, risk assessment, mitigation planning, investigations, and validation strategy development.
  • Support production issue resolution, process and capacity optimization, continuous process verification, and performance monitoring.
  • Coordinate with Operations, Quality, Regulatory, Procurement, Commercialization, and external partners to achieve compliant, inspection-ready product introductions and transfers.

Requirements

  • Bachelor’s degree in Engineering, Science, or Business.
  • At least 8 years of post-bachelor’s experience in drug substance and/or drug product vaccines or biologics manufacturing, engineering, and/or technical operations support.
  • Expertise and demonstrated accomplishments leading technical transfers.
  • Advanced problem-solving skills and experience leading teams through complex business or technical issues.
  • Strong leadership, collaboration, change management, interpersonal, analytical, verbal communication, and written communication skills.
  • Experience with biologics manufacturing, process sciences, analytics, technical support, and external manufacturing operations.
  • Ability to travel approximately 25–30% within the designated US region and accept flexibility in partner assignment location.

Nice to have

  • Advanced degree in Engineering, Science, or Business.
  • Experience leading cross-functional manufacturing operations teams at internal sites or external partners.
  • Expertise in Lean Manufacturing applications and productivity improvement.
  • Experience motivating teams around a common vision and delivering expected results.
  • Engineering fundamentals, process troubleshooting, creative problem-solving, and self-directed work style.
  • Experience in complex international matrix organizations.
  • Experience designing, starting up, and/or operating large-molecule unit operations.

Culture & Benefits

  • Collaborative work across Operations, Quality, Regulatory, Procurement, Commercialization, and external partners.
  • Regular day shift with a regular employee status.
  • Medical, dental, vision, insurance, retirement benefits including 401(k), paid holidays, vacation, compassionate leave, and sick days.
  • Inclusive environment that values diverse perspectives, respectful challenge, and collective problem-solving.
  • Relocation is not available; visa sponsorship is not available.

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