This position is an exciting leadership opportunity within the Attribute Sciences group based at Amgen’s Thousand Oaks, CA headquarters. The Principal Scientist will lead a dynamic team with broad responsibility for developing, qualifying and transferring state-of-the-art and fit-for-purpose biological assays in support of potency assessment and biological characterization of Amgen’s therapeutics. This will involve working on a wide range of modalities including antibodies, engineered proteins, multi-specific molecules, as well as novel therapies.
Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization, and reference standard characterization
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
Managing a team or teams of staff that contribute to the achievement of department and project objectives
Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions
Analyzing and interpreting analytical data to support: product development investigations and regulatory submissions
Contributing to critical analytical development teams (e.g., Product and Process Development teams, Product Quality teams) by providing analytical updates, analytical documentation and data interpretation
Authoring detailed analytical procedures for lot release, stability and product characterization testing
Adhering to program deliverables such as timelines, milestones, methodological approaches, expected results, and necessary resources
Keeping current in analytical development field including literature and technology development for cutting edge and regulatory driven activities
Driving the development of key scientific strategies and objectives within the function
Providing critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions
PhD in Cell Biology, Molecular Biology, Immunology, Biochemistry, or similar disciplines
Experience in requisite authoring or regulatory submissions
Expertise in cell culture and cell biology techniques for the quantitative determination of biological activity of proteins
Expertise in cell-based and non-cell-based potency assay development (method optimization, qualification, validation, technical transfer)
Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies
Leadership – provides clear and consistent vision and direction using an appropriate leadership style; builds teamwork and collaboration
Experience with authoring and critical review of regulatory filings: Investigational New Drug (IND), Biologic(s) License Application (BLA), New Drug Application (NDA)
Proven experience to interact with regulatory agencies during inspections and face-to-face meetings
Proven ability to expand analytical development expertise to a broader level of understanding in pharmaceutical R&D and commercialization
Resource management – ensures resources are utilized fully and productively and that adequate resources are projected and selected to accomplish unit responsibilities
Innovation oriented – positive approach to challenges; champions new ideas and initiatives; brings out and utilizes the creativity of the team to improve unit performance
Client oriented– establishes effective and responsive relationships with all clients; translates client requirements into work design; ensures value is delivered
Performance management – ensures direct reports are oriented and developed to perform at a high level; monitors performance and provides adequate feedback through coaching and effective performance appraisal and development planning
Communication – establishes and maintains effective communication mechanisms to keep staff appropriately informed; bridges communication between individuals, units and other organizations
Interpersonal skills – communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood
Doctorate degree and 3 years of Scientific experience
Master’s degree and 6 years of Scientific experience
Bachelor’s degree and 8 years of Scientific experience
About Amgen, Inc.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.