Manufacturing Process Expert
hace 4 semanas
About the Role
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.
Your Mission
As a Manufacturing Process Expert, you will be responsible for:
- Evaluating and assessing manufacturing processes for semi-finished and finished pharmaceutical products
- Developing and implementing manufacturing transfer strategies for new products
- Managing and reviewing documentation provided by CMOs, including master batch records and process validation reports
- Writing and approving technical documentation for the EMM department
- Providing technical support and coordination with CMOs, QC and QA specialists, and regulatory specialists
Requirements
To be successful in this role, you will need:
- A Bachelor's degree in pharmacy or chemistry
- Minimum 1-2 years of experience in technology transfer in an external manufacturing department of a pharmaceutical company
- Extensive knowledge of specific manufacturing processes for pharmaceutical products, including FDFs, oral solid forms, and injectable products
- Good understanding of GMP guidelines, change control procedures, and quality support
- Intermediate level of English and Spanish
About Us
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS). We have a unique understanding of the CNS market built over 35 years and are constantly innovating to address unmet patient needs. We are expanding our portfolio through our pipeline and acquisitions and have a direct presence in over 20 countries in Europe, two in Latin America, and globally via partners in over 40 countries.
What We Offer
We offer a competitive remuneration package, individual professional development opportunities, and an inspiring leadership team that drives performance. We are an inclusive culture promoting diversity across the teams and offer a passionate, dynamic, result-focused, and expert & excellent team environment.
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