Manufacturing Process Specialist
hace 7 días
About the Role
We are seeking a highly skilled Manufacturing Process Specialist to join our team at Neuraxpharm. As a key member of our External Manufacturing Management department, you will be responsible for evaluating and assessing manufacturing processes for semi-finished and finished pharmaceutical products.
Your Key Responsibilities
- Evaluate and assess manufacturing processes for semi-finished and finished pharmaceutical products
- Develop and implement manufacturing transfer strategies for assigned projects
- Manage and review documentation provided by receiving unit CMOs
- Write and approve technical documentation in accordance with current quality regulations
- Provide technical support and coordination with Tech Transfer responsible of CMOs, QC & QA specialists, and regulatory specialists
Requirements
- Bachelor's degree in pharmacy or chemistry
- Minimum 1-2 years of experience in technology transfer in External Manufacturing Department of a pharmaceutical company
- Extensive knowledge of specific manufacturing processes for pharmaceutical products
- Intermediate level of English and Spanish
- Specific knowledge of Quality Systems, GMPs, GLPs, Pharmacopoeia, ICH regulations, and Office tools (MS Office) and LIMS and SAP software
- Key capabilities: analytical thinking, team player mentality, organizational and prioritization skills
About Us
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. We have a unique understanding of the CNS market built over 35 years.
We are constantly innovating, with new products and solutions to address unmet patient needs and are expanding our portfolio through our pipeline and acquisitions.
The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, and globally via partners in more than 40 countries. Neuraxpharm is backed by funds advised by Permira.
We offer a dynamic and inclusive culture that promotes diversity across our teams. Our leadership team drives performance, and we provide individual professional development opportunities in a leading European pharmaceutical company with an ambitious international growth strategy.
We offer attractive remuneration according to experience and skills provided, and an inspiring leadership team that drives performance. We are passionate, dynamic, result-focused, and expert & excellent team that will inspire you every day.
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