Senior Manager, Analytical Development Lead
This role offers the opportunity to lead and forge partnerships that advance analytical science in support of delivering superior drug substance and product manufacturing processes.
Main Responsibilities:
* Provide scientific and technical leadership in support of troubleshooting method related testing challenges, incoming method transfer and development/commercial investigations.
* Implement and provide leadership for implementation of state-of-the-art and fit-for-purpose analytical methods for in-process, release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions.
* Maintain strong partnerships with global network stakeholders e.g., Product Delivery Teams (PDT's), all Process Development groups, Regulatory, Quality and sister sites to positively influence Amgen practices and strategies to ensure success through the life cycle of current and future commercial products.
Requirements:
* Doctorate degree and 2 years of experience in pharmaceutical/biotech process and product development and analytical method development or equivalent experience.
* Demonstrated knowledge of analytical methods/technologies such as Chromatography, CE, General Assays, Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, recombinant proteins and recombinant PEGylated proteins.
* Strong problem solving, trouble shooting, and communication skills are required for this position.