Preclinical Development and CMC Associate

 

Through cutting-edge science and medicine, Biogen Idec passionately seeks to discover, develop and deliver to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company and generates nearly $5 billion in annual revenues. Biogen Idec strives to make work a rewarding experience that has purpose and opportunity to make a difference. With patients worldwide benefiting from its leading multiple- sclerosis therapies, Biogen Idec not only changes the lives of patients and those in the community, it changes the lives of its own employees. For additional information about the company and positions available, please visit www.biogenidec.com/careers.

Job title: Preclinical Development and CMC Associate

Reports to: VP, Head of Chemistry and Preclinical Development

Location: Maidenhead, UK                                

 

Job purpose:

To maintain and coordinate all day-to-day administrative aspects of Convergence Preclinical Development activities.

In association with Quality Department to monitor Preclinical Development activities and documentation for compliance with GLP, GMP & (where appropriate) GCP regulations and convergence SOPs.

 

Principal Accountabilities

·         Responsible for the organization, set-up and maintenance of toxicology, DMPK and CMC sections of the Product Development files.

·         Responsible for the organization and maintenance of electronic filing areas for Preclinical Development.

·         Responsible for the administrative requirements of contracts, protocols, study reports, batch records, correspondence and other Preclinical Development documentation.

·         Development and maintenance of the Product Specification File.

·         Provide administrative support to the Head of Chemistry and Preclinical Development.

·         Support the Quality requirements of Convergence including the review of SOPs and the preparation and review of Technical/Quality agreements.

·         As required participate in Quality review and audit of CROs and CMOs.

·         Monitor and review archiving agreements of CROs/CMOs and organize transfer to Convergence archive as needed.

·          As required maintain an inventory of drug supplies.

·         Organize and provide oversight for the logistics of drug shipments according to regulatory requirements.

 

Qualifications required for the role:

·         Pharmaceutical research and/or development expertise, ideally 5 years in a relevant discipline/role.

·         Experience of working in a regulated environment.

·         Highly organized and responsive to the needs of multiple work streams.

·         Preferred – some understanding of CMC and/or cGMP regulations.

 

Education:

·         Degree in a scientific discipline.

 

To make an application for this role please submit your CV to evie.baldwin@biogen.com