7 часов назад
Associate Director, New Product Introduction (Drug Product)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, New Product Introduction (Drug Product): Leading technology transfer and late-phase and commercial drug product introduction at a Swiss manufacturing site with an accent on oral solid dosage, process scale-up, and cGMP compliance. Focus on guiding cross-functional NPI teams, supporting PPQ and commercial launch readiness, and resolving complex production and regulatory challenges.
Location: Couvet, Switzerland; on-site
Company
operates a growing pharmaceutical manufacturing site supporting the technology transfer and commercial introduction of drug products.
What you will do
- Lead end-to-end technology transfers from internal development sites, client sites, and third-party facilities into the Couvet manufacturing site.
- Lead and mentor the NPI team while coordinating matrixed cross-functional project teams.
- Select, evaluate, and scale process technologies, tooling, and methods for late-phase and commercial drug products.
- Develop and optimize critical process parameters and critical quality attributes, and troubleshoot production batches and complex deviations.
- Coordinate technical, registration, clinical, stability, PPQ, and commercial launch batches to support on-time delivery.
- Act as the primary NPI contact for clients and support process validation, continued process verification, commercial readiness, and pre-approval inspections.
Requirements
- Bachelor’s degree or higher in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific or engineering discipline.
- 10–15+ years of pharmaceutical industry experience in Technical Operations, R&D, MS&T, or NPI management.
- At least 3 years of leadership experience focused on Drug Product processes, technology transfer, and scale-up.
- Experience with Oral Solid Dosage is required. Knowledge of late-phase and commercial drug product manufacturing is essential.
- Working knowledge of FDA, EMA, cGMP, ICH guidelines, SUPAC, and other global regulatory requirements.
- Fluent English, with strong communication, stakeholder management, matrix leadership, organizational, and project management skills.
Nice to have
- Experience with injectable drug products.
- PMP certification.
Culture & Benefits
- Opportunity to shape NPI strategy at a rapidly growing manufacturing facility.
- Fast-paced and dynamic work environment with ambiguity typical of a growing site.
- Focus on trust, personal accountability, continuous improvement, and high safety standards.
- Opportunity to support the delivery of life-changing pharmaceutical products to clinical and commercial markets.
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