Manufacturing Process Expert
hace 5 días
We are seeking a highly skilled Manufacturing Process Expert 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.
Key Responsibilities- Evaluate and assess manufacturing processes for semi-finished and finished pharmaceutical products, including sterile products and pharmaceutical finished products.
- Develop and implement a manufacturing transfer strategy for assigned projects, including manufacturing process transfer/validation strategy, raw materials GAP analysis, packaging materials GAP analysis, and GMP guidelines.
- Write or approve technical documentation for the EMM department in accordance with current quality regulations.
- Provide technical support and coordination with Tech Transfer responsible of CMO's, QC & QA specialists, and regulatory specialists.
- Manage and review documentation provided by receiving unit CMO's, collect Master Batch records from sending unit CMO's, and review and file into NxP QMS system.
- Write technical reports and SOP's, and continuously learn to stay updated on manufacturing process and validation requirements.
- Support Regulatory Affairs team to answer deficiency letters from agencies or clients' queries in life cycle management projects.
- Support QA department with regards to any quality topic from manufacturing process for assigned projects.
- Support CMO Management department in sharing critical tech details that could affect CMO selection for new projects.
- Bachelor's degree in pharmacy or chemistry.
- Minimum 1-2 years of experience as Technology Transfer in External Manufacturing department of a pharmaceutical company.
- Extensive knowledge of specific manufacturing processes for pharmaceutical products, including FDF's, oral solid forms, oral liquid forms, injectable products, and GMP guidelines.
- 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.
- Availability to travel: 30%.
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.
We have c. 1,000 employees and develop and commercialize 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 manufacture many of our pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.
What We Offer- Individual professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
- Attractive remuneration according to experience and skills provided.
- An inspiring leadership team that drives performance.
- An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, dynamic, result-focused, and expert & excellent team
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