7 дней назад
Senior Process Scientist (LNP)
59 000€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Process Scientist (LNP): Developing and overseeing lipid nanoparticle formulation and manufacturing processes for nucleic acid delivery and gene therapy programs with an accent on scale-up, technology transfer, GMP manufacturing, and process controls. Focus on leading outsourced CRO/CDMO activities, troubleshooting complex biologics processes, designing QbD-based control strategies, and supporting CMC documentation through clinical development and commercial launch.
Location: Anywhere in Europe, with hybrid and remote options
Salary: Minimum €59,000 annually when the role is based in Italy; compensation and benefits vary by local market.
Company
is an international research-focused biopharmaceutical group developing and commercializing medicines, including treatments for rare and ultra-rare diseases.
What you will do
- Lead formulation, lipid and excipient screening, LNP process development, manufacturing, and control strategy for assigned gene therapy projects.
- Advance in vivo LNP programs from candidate selection through clinical development, commercial launch, and lifecycle management.
- Oversee technology transfers and outsourced development activities with CROs and CDMOs, including partner selection, qualification, governance, and performance monitoring.
- Review technical plans, batch records, SOPs, development reports, validation protocols, and other manufacturing documentation.
- Lead troubleshooting, root-cause investigations, deviation assessments, risk management, and continuous improvement activities.
- Support CMC strategy, regulatory documentation, external business development evaluations, and cross-functional project execution.
Requirements
- Minimum MSc in biotechnology, bioengineering, biology, biochemistry, chemistry, chemical engineering, or a related field.
- 5–10 years of relevant industrial experience in biotechnology or pharmaceuticals, including gene editing, CGT/ATMPs, and LNP-based delivery systems.
- Expertise in LNP formulation optimization, process development, scale-up, GMP technology transfer, process validation, and formulation and process parameters linked to CQAs.
- Experience with microfluidics, T-mixers, inline mixing, continuous processing, QbD, DoE, CPP/CQA identification, control strategies, and risk assessment.
- Experience managing CRO/CDMO development activities, technical oversight, troubleshooting, escalation management, and data-driven performance monitoring.
- Strong understanding of GMP, regulatory requirements, CMC development, technical writing, data review, and stakeholder management in an international matrix organization.
Culture & Benefits
- Research-focused environment centered on sustainable innovation, reliability, transparency, and ethical behavior.
- Flexible hybrid and remote working arrangements within Europe.
- Annual performance-based bonus eligibility.
- Benefits may include pension, private medical insurance, wellbeing programs, flexible benefits, healthcare programs, and work-life balance initiatives.
- Relocation support, tax assistance for foreign colleagues, and access to training and development resources.
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