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2 часа назад

Senior Manager, MSAT Sterile Ops Technical Team

130 000 - 193 750$
Тип работы
fulltime
Грейд
senior
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
Senior Manager, MSAT Sterile Ops Technical Team (biomanufacturing): Leading a technical MSAT team responsible for transferring and implementing fully qualified processes, capabilities, and equipment in a cGMP manufacturing environment with an accent on aseptic operations, validation, and technology transfer. Focus on guiding tech transfer from initial evaluation through PPQ, documenting risk-based technical decisions, and developing compliant, continuously improving manufacturing processes.

Location: USA - OH - West Chester

Salary: $130,000–$193,750 per year

Company

hirify.global is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.

What you will do

  • Lead and coach the MSAT Technical team supporting technology transfer and process implementation.
  • Develop and maintain standards and best practices for site technology transfer activities.
  • Provide technical support throughout the technology transfer process, from initial evaluation through PPQ.
  • Ensure technical decisions are documented using GMP practices, risk management, data, and scientific principles.
  • Collaborate with PMO, Validation, Quality, Operations, equipment suppliers, and material suppliers.
  • Evaluate new technologies, develop business cases, present technical data, and drive continuous improvement.

Requirements

  • Extensive experience in aseptic operations, formulation, aseptic filling, visual inspection, device assembly, or packaging in a regulated environment.
  • Experience with technology transfer in a GMP environment.
  • Strong leadership, coaching, communication, and influencing skills.
  • Ability to work effectively in a team environment and independently under the direction of the site MSAT Lead.
  • Ability to follow SOPs, cGMPs, safety procedures, OSHA requirements, and company EHS guidelines.
  • Sponsorship or support for work authorization, including visas, is not available.

Nice to have

  • Bachelor’s degree in engineering or a related discipline.
  • Ability to generate and interpret technical documents.
  • Experience managing external technical relationships.
  • Lean Six Sigma or lean manufacturing training or awareness.

Culture & Benefits

  • Annual cash bonus program and 401(k) plan with company match.
  • Medical, dental, and vision coverage, life and disability insurance.
  • Paid vacation, paid holidays, and other paid leave.
  • Tuition reimbursement, family-building benefits, and caregiving support.
  • Employees must demonstrate and maintain gown qualification standards for sterile operations.

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