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2 дня назад

Quality Control Manager (Biotech)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
UK/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
Quality Control Manager (Biotech): Performing GMP-compliant QC testing and managing laboratory systems, assay transfers, validations, investigations, and documentation with an accent on laboratory operations, regulatory readiness, and method optimization. Focus on leading QC staff, introducing and validating laboratory equipment, troubleshooting analytical methods, and coordinating samples, vendors, and external technical studies.

Location: Milton Park, United Kingdom; on-site with a typical 5-day on-site expectation

Company

hirify.global is a biotechnology company developing oncolytic immunotherapies designed to stimulate durable systemic anti-tumor responses.

What you will do

  • Perform QC testing in accordance with SOPs and current Good Manufacturing Practices.
  • Maintain QC laboratory systems, equipment, samples, reagents, and retain inventory.
  • Generate protocols and reports for assay transfers and validation activities.
  • Author and review SOPs, forms, deviations, change controls, CAPA documentation, and Certificates of Analysis.
  • Lead or support OOS, OOT, laboratory, troubleshooting, and method-optimization investigations.
  • Coordinate QC activities with internal departments, contract laboratories, vendors, and regulatory inspections.

Requirements

  • Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or a related science.
  • At least 4 years of relevant GLP/GMP experience.
  • Experience with QC testing, assay transfer or validation, laboratory equipment, and GMP documentation.
  • Computer literacy, including Microsoft Word and Excel.
  • Effective communication, organization, collaboration, and training skills.
  • Ability to work on-site at Milton Park five days per week.

Culture & Benefits

  • Purpose-driven work focused on transforming cancer treatment and improving patient outcomes.
  • Collaborative culture based on united, audacious, dedicated, and candid values.
  • Opportunity to lead or train junior QC staff and act as a subject-matter expert for methods and processes.
  • Competitive and forward-looking total rewards program.

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