Amgen Principal Scientist - Biological Relevance and Characterization in Cambridge, Massachusetts

This position is an exciting leadership opportunity within the Attribute Sciences group based at Amgen's Cambridge site in Boston. 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 including potency and biological characterization. This will involve working on a wide range of modalities including antibodies, engineered proteins, multi-specific molecules as well as novel therapies.

Responsibilities include:

Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations

Managing a team or teams of bioassay 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

Participating or 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

Planning detailed analytical procedures for lot release, stability and product characterization testing, including 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

Leading the development of key scientific strategies and determines objectives within the function

Designing and implementing analytical projects involving method development, qualification, and transfer

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

HJUS2017

*LI-Post

Basic Qualifications:

Doctorate degree and 2 years of Scientific experience

OR

Master's degree and 6 years of Scientific experience

OR

Bachelor's degree and 8 years of Scientific experience

OR

Associate's degree and 10 years of Scientific experience

OR

High school diploma / GED and 12 years of Scientific experience

Preferred Qualifications:

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

Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines

Experience with authoring and critical review of regulatory filings: Investigational New Drug (IND), Biologics License Application (BLA) and New Drug Application (NDA)

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 others' creativity 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

Leadership - provides clear and consistent vision and direction using an appropriate leadership style; builds teamwork and collaboration

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

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.

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.