Senior Pharmaceutical Release Manager
Vor 2 Tagen
Job Summary: Biogen seeks a highly experienced Senior Pharmaceutical Release Manager to lead the commercial release team and ensure compliant Medicinal Product supply to approved markets. This role is ideal for individuals with a strong background in the pharmaceutical industry and excellent leadership skills.
Responsibilities:
- Oversee the commercial release team and RP release delegates to ensure timely completion of full release packages for EU/US products.
- Collaborate with CMOs to develop manufacturing strategies that maintain supply chain integrity.
- Contribute to technology transfer and process updates, ensuring compliance with cGMP requirements and EU/FDA regulations.
- Manage stakeholders and identify compliance gaps, supporting the quality system and ensuring serialization/data integrity.
Requirements:
- Bachelor's degree in a scientific field (Pharmacy, Chemistry, Biology, etc.).
- At least 10 years of experience in pharmaceutical or biotechnology industries.
- Strong knowledge of cGMP requirements, EU/FDA regulations, and compliance.
- Candidates with people management experience and effective working relationships will be preferred.
About Us:
Biogen is a global leader in developing therapies for neurological and rare diseases. Our mission is to follow the science and make an impact on patients' lives, striving to change the course of medicine.
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