обновлено 2 дня назад
Project Lead QC (Biologics)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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