Scientist - Biological Relevance and Characterization - Process Impurities
Amgen (NASDAQ:AMGN), a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.
This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative assays for the measurement of DNA, proteins and other biological analytes for manufacturing process development and supporting regulatory submissions.
Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: impurity release testing, product characterization/optimization, and investigations.
Generating, analyzing, and interpreting analytical data and results to support: method development, product development (for Process Development, Quality, etc.), investigations, and regulatory submissions.
Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions. Provides critical evaluation of analytical data and results to support product development (for Process Development, Quality, etc.), investigations and regulatory submissions.
Designing and implementing analytical projects involving method development, qualification, and transfer; monitoring method performance metrics across multiple testing sites and devising plans to address method performance issues.
Participate or contribute to critical analytical development teams (e.g., Attribute Sciences teams, Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation.
Plans and manages the generation of detailed analytical procedures used for product lot release, and/or characterization, including timelines, milestones, methodological approaches, expected results, and necessary resources.
May manage a team of lab associates to accomplish project deliverables.
Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities.
Doctorate degree in Immunology, Molecular Biology, or Biochemistry discipline
Masters degree + 4 years of Scientific experience
Bachelors degree + 6 years of Scientific experience
Experience and expertise with molecular biology, particularly qPCR assay development (method optimization, qualification, validation, technical transfer) and DNA isolation for the quantitative determination of large molecule therapeutics process impurity assessment.
Experience and expertise with immunoassay development (method optimization, qualification, validation, technical transfer) particularly with regard to quantitative determination of large molecule therapeutics process impurity assessment.
Experience and expertise with Microsoft Office software, particularly Word, PowerPoint and Excel.
Experience working in a GMP environment is desirable.
Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines preferred
Ability to expand analytical development expertise to a broader level of understanding in R&D and commercialization
Experience with automation is desirable
Innovation positive approach to challenges; champions new ideas and initiatives; brings out and utilizes others creativity to improve group performance
Client orientation establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered; works well in teams
Performance management may ensure direct reports are adequately oriented and developed to perform at a high level; monitors performance and provides adequate feedback through coaching and effective performance appraisal and development planning
Leadership supports teamwork and collaboration
Communication establishes and maintains effective communication mechanisms to keep staff appropriately informed; bridges communication between individuals, units and other organizations as necessary
Interpersonal skills communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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.