Process Development Senior Scientist

Process Development Senior Scientist

This position is an exciting leadership opportunity within the Attribute Sciences group based at Amgen's Thousand Oaks, CA headquarters. The Senior Scientist will lead a dynamic team with broad responsibility for developing and defining the strategy and the state-of-the-art and fit-for-purpose analytical method in support of excipients and process reagents of Amgen's therapeutics. This will involve working on a wide range of processes, and modalities including antibodies, engineered proteins, multi-specific molecules, as well as novel therapies.

Responsibilities include:

Defining and developing guiding principles and strategies for excipient and process reagents and reagent clearance evaluation

Driving the development of key scientific strategies and objectives within the function

Interacting with key stake and opinions holders including external peers and regulators to drive Amgen's vision, science, and strategy

Keeping current in analytical development field including literature and technology development for cutting edge and regulatory driven activities

Developing and implementing state-of-the-art and fit-for-purpose analytical methods for excipients and process reagents

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

Leading 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

Providing critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), 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

Adhering to program deliverables such as timelines, achievements, methodological approaches, expected results, and necessary resources

Day to Day Duties:

Leading a team of staff to achieve function's goals

Providing technical guidance to the team

Serving as subject matter expert cross functionally

Basic Qualifications

Doctorate degree and 2 years of directly relevant scientific experience

Or

Master's degree and 5 years of directly relevant scientific experience

Or

Bachelor's degree and 7 years of directly relevant scientific experience

Preferred Qualifications:

PhD in Analytical chemistry, Biotechnology, Biochemistry, or similar disciplines

Extensive technical experience and expertise in:

Requisite authoring or regulatory submissions

Analytical techniques for the quantitative determination of excipients and reagents

Assay development (method optimization, qualification, validation, technical transfer)

Protein purification process

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)

Confirmed experience to interact with regulatory agencies during inspections and face-to-face meetings

Validated ability to expand analytical development expertise to a broader level of understanding of excipients and reagents

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

Proven experience with raw materials characterization

Resource management - ensures resources are utilized fully and productively and that adequate resources are projected and selected to accomplish unit responsibilities

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 demonstrates 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.

Join Us

If 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.