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 Amgen’s 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
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is an individual with these qualifications.
Basic Qualifications
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
OR
Master’s degree and 3 years of Scientific experience
OR
Bachelor’s degree and 5 years of Scientific experience
Preferred Qualifications
Doctorate degree with 5 years in Analytical Chemistry, Biochemistry or equivalent.
Relevant experience working as part of a multidisciplinary team in a biopharmaceutical setting would also be an advantage.
Strong background in analytical method development of biologics such as monoclonal antibodies and multispecifics.
Proficient in mass spectrometry techniques including intact mass and peptide mapping assays for characterizing biologic therapeutics
Proficient in other HPLC and CE methods such as reversed-phased HPLC, size-exclusion HPLC, ion-exchange HPLC, affinity HPLC, CE-SDS, and cIEF for biologics
Demonstrate knowledge of regulatory requirements and guidelines and prior experience authoring or contributing to regulatory filings.
