Amgen

Process Development Principal Scientist

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Mar 22, 2019
Ref
R-62224
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Responsibilities include:

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

Basic Qualifications

Doctorate degree and 3 years of Scientific experience

OR

Master's degree and 6 years of Scientific experience

OR

Bachelor's degree and 8 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

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

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.