Process Development Sr Scientist Thousand Oaks
Job Location:
Thousand Oaks, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Process Development Sr Scientist
What you will do
Lets do this. Lets change the this vital role you will join Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities including (but not limited to) synthetic medicines monoclonal and bispecific antibodies bispecific T-cell engagers and live oncolytic viruses. Located at our Thousand Oaks CA office the PD Senior Scientist will work to provide strategic analytical leadership (as an Attribute Sciences team lead) to teams developing commercializable manufacturing processes and collaborate closely with Drug Substance and Drug Product colleagues.
Supervise and provide technical support for a team that provides analytical support for late stage product development
Act as an Attribute Sciences Team lead for a program in pivotal clinical process development being responsible for all analytical work to support the program
Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP oversee the development qualification remediation and transfer of analytical methods to Quality Control
Manage activities at contract manufacturing and testing sites
Author technical reports and analytical Chemistry Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
Drive product characterization in support of process comparability studies regulatory filings regulatory questions and reference standard qualification
Provide expertise and evaluation of Amgens platform and analytical technologies helping to drive innovation and efficiency within Process Development
Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
Required Experience:
Senior IC
About Company
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