Amgen Process Development Scientist - Pivotal Attribute Sciences in Thousand Oaks, California
Amgen's 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) monoclonal and bispecific antibodies, bispecific T-cell engagers ('BiTEs'), live oncolytic viruses, and synthetic medicines.
Located in our Thousand Oaks, CA office, the PD Scientist will work supporting product characterization / method development and as an Attribute Sciences Team lead/liaison for clinical candidate molecules in the pivotal stage of development.
Key responsibilities include:
Testing and characterization of protein and synthetic products: Design and execute studies, interpret results, author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
Hands-on development, qualification, remediation, and transfer of analytical methods to Quality Control. Author technical protocols, reports and Standard Operating Procedures (SOPs) for analytical methods. Serve as analytical subject matter expert to support investigations and studies carried out by other functional areas.
Determining clinical product critical quality attributes through risk assessment, and defining the product quality target product profile to define process development.
Defining the analytical target profile for the methods used to monitor product quality.
Oversee the development and characterization of all methods used to test the product.
Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions and reference standard qualification.
Represent the Attribute Sciences department at all product delivery team meetings.
Closely collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.
Answer analytical and product quality questions from health authorities.
Providing expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience
M.S. in Biochemistry
Strong scientific background in biologics method development and product characterization
Ability to lead transversal project teams, previous managerial experience
3+ years' experience in industrial analytical laboratories supporting method development and testing of commercial or clinical protein products
Demonstrated proficiency in solving complex problems, ability to work independently, proactively seek outside resources and collaborate, self-starter and team player with strong leadership and decision-making skills capable of providing mentorship to junior staff
Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.