16 часов назад
Senior Principal Scientist/Principal Scientist - Scientific Integration, Analytical Development (AI)
96 000 - 165 025€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Principal Scientist/Principal Scientist - Scientific Integration, Analytical Development (AI): Leading integrated analytical development and control strategies for synthetic pharmaceutical modalities across the product lifecycle with an accent on CMC strategy, regulatory readiness, and cross-functional scientific leadership. Focus on designing phase-appropriate methods and specifications, resolving complex analytical risks, and applying AI-enabled and modelling approaches to improve development decisions.
Location: Beerse, Antwerp, Belgium; position based at the Beerse R&D facility with up to 15% domestic and international travel.
Base pay: €96,000–€165,025 per year, plus an annual bonus and employee benefits.
Company
Johnson & Johnson Innovative Medicine develops science-based healthcare solutions and medicines across global analytical development hubs in the US, Asia, and Europe.
What you will do
- Own the Analytical Development strategy for CMC product-development projects, including deliverables, resources, timelines, budgets, and governance.
- Represent Analytical Development as the primary scientific contact across CMC teams, API and drug-product functions, supply chain, quality, regulatory affairs, and external partners.
- Develop integrated, fit-for-purpose analytical and control strategies across feasibility, preclinical development, clinical development, and commercialization.
- Lead multidisciplinary activities covering method development and validation, release and stability, characterization, dissolution, pharmaceutical sciences, and material sciences.
- Set, justify, and manage drug-substance and drug-product specifications, retest periods, and shelf-life assignments.
- Identify and resolve analytical risks while applying digital, AI-enabled, and modelling approaches to support risk-based decisions.
Requirements
- Master’s degree in chemistry, pharmacy, or an equivalent scientific discipline; a PhD or other advanced scientific degree is preferred.
- At least 8 years of pharmaceutical-industry experience with strong scientific expertise in analytics, method development, stability, and specifications.
- Experience with one or more synthetic modalities, such as small molecules, oligonucleotides, peptides, or conjugates.
- Knowledge of global regulatory requirements, cGMP, FDA and ICH guidance, SOPs, and risk-based quality principles.
- Experience leading cross-functional teams and influencing stakeholders in a highly matrixed organization.
- Fluency in written and spoken English is essential. Dutch is an advantage.
Culture & Benefits
- International and dynamic working environment with continuous learning and growth opportunities.
- Inclusive workplace where different perspectives are respected and valued.
- Vacation, parental, bereavement, caregiver, and volunteer leave.
- Annual bonus, wellbeing reimbursement, financial, physical, and mental health programs.
- Access to insurance plans, service-anniversary recognition, and other employee programs.
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