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Project Lead QC (Biologics)

Формат работы
hybrid
Тип работы
fulltime
Грейд
lead
Английский
c1
Страна
Switzerland
Релокация
Switzerland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Project Lead QC (Biologics): Leading quality control projects for release and stability testing of late-phase and commercial drug products, with an accent on analytical method transfers, testing strategies, and GMP-compliant documentation. Focus on coordinating customer-facing QC delivery, assessing laboratory capacity, and providing scientific and regulatory guidance for large molecules and Antibody Drug Conjugates.

Location: Stein, Aargau, Switzerland. Primarily on-site, with remote work permitted for no more than 20% of the time. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global manufactures medicines for customers through globally connected life sciences sites and cross-functional teams.

What you will do

  • Lead and coordinate QC activities for release and stability testing of late-phase and commercial drug products, focusing on large molecules and Antibody Drug Conjugates.
  • Act as the primary QC representative for customers and project stakeholders, coordinating timelines, deliverables, communications, and project execution.
  • Assess laboratory capacity and coordinate analytical method transfers to support timely implementation of testing.
  • Develop analytical testing strategies, including method suitability assessments, performance evaluation, control strategies, and specification setting.
  • Author quality records and cGMP documentation, including procedures, source documents, reports, deviations, and change requests.
  • Provide QC subject-matter expertise during audits, inspections, and customer meetings while maintaining regulatory readiness.

Requirements

  • Experience in a GMP-regulated pharmaceutical Quality Control environment.
  • Strong understanding of analytical testing for biologics and large molecules.
  • Strong collaboration and stakeholder-management skills, including customer and cross-functional communication.
  • Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related life sciences discipline.
  • Fluent English is required.

Nice to have

  • Experience with project coordination, analytical method validation, or analytical method transfer.
  • Fluent German.

Culture & Benefits

  • Agile career environment and dynamic work culture.
  • Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
  • Competitive salary and performance-oriented compensation programs.
  • Lifestyle, family, and leisure benefits.

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