5 дней назад
CMC Biologics Analytical Lead – Principal Scientist
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
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TL;DR
CMC Biologics Analytical Lead – Principal Scientist (Biologics): Leading analytical strategy, method development, and oversight across the biopharmaceutical development lifecycle with an accent on bioanalytical strategy, regulatory readiness, and external partner coordination. Focus on developing and validating fit-for-purpose analytical methods, managing analytical risks, and aligning cross-functional stakeholders through commercialization readiness.
Location: Sant Feliu de Llobregat, Spain; Remote
Company
develops medical dermatology products focused on unmet patient needs and innovation that improves patients’ lives.
What you will do
- Define and lead bioanalytical strategy, priorities, development plans, and milestones across early development, late-stage development, and commercialization readiness.
- Coordinate analytical activities with CMC, process development, formulation, quality, regulatory, manufacturing, and other internal stakeholders.
- Provide scientific oversight of external analytical laboratories, CDMOs, and specialist service providers, including deliverables, timelines, data packages, and issue resolution.
- Oversee analytical method development, qualification, validation, transfer, and lifecycle management for characterization, release testing, stability, and comparability studies.
- Support analytical CMC regulatory submissions, agency interactions, inspections, and responses to regulatory questions.
- Manage analytical risks, resolve complex technical challenges, and drive continuous improvement and knowledge sharing.
Requirements
- Advanced degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, or a related field; PhD preferred or equivalent experience.
- Strong experience in analytical development, bioanalytical sciences, or CMC analytical functions within the biopharmaceutical or pharmaceutical industry.
- Experience coordinating analytical activities and providing scientific oversight across multiple development stages.
- Strong understanding of analytical method development, qualification, validation, transfer, and lifecycle management.
- Experience managing external partners in complex, cross-functional development environments.
- Knowledge of regulatory expectations and quality requirements for analytical development and CMC documentation.
- Proven ability to lead technical discussions, align stakeholders, manage competing priorities, and deliver against milestones.
Culture & Benefits
- Work in an environment focused on independent thinking, ownership, meaningful impact, and continuous improvement.
- Collaborate with internal analytical, CMC, quality, regulatory, manufacturing, and external partner teams.
- Recognised as a Top Employer in Spain since 2008 and in Germany since 2025.
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