Process Development Scientist - Effector Function and Characterization
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Process Development Scientist - Effector Function and CharacterizationLive
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions. .Role Responsibilities:
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
Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions
Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions
May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
Plans detailed analytical procedures for GLP and GMP activities for release and stability testing, including timelines, breakthroughs, methodological approaches, expected results, and necessary resources
May supervise GLP lot release or stability testing activities
Keeps current in analytical development field including literature and technology development for groundbreaking and regulatory driven activities
Crafting and implementing analytical projects involving method development, qualification, and transfer
Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions
Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications.Basic Qualifications
Masters degree and 4 years of life science industry experience
Bachelors degree and 6 years of life science industry experiencePreferred Qualifications:
Expertise in cell and tissue culture, and cell biology techniques for quantitative determination of biological activity of proteins
Expertise in cell-based bioassay development (method characterization, qualification, validation, technical transfer)
Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies
Experience with Surface Plasma Resonance (SPR) techniques using Biacore
Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines
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 efficiently and that adequate resources are projected and selected to accomplish unit responsibilities
Innovation positive approach to challenges; champions new insights and initiatives; brings out and utilizes others creativity to improve unit performance
Client orientation establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered
Performance management ensures direct reports are adequately oriented and developed to perform at a high standard; supervises performance and provides adequate feedback through mentor 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 as necessary
Interpersonal skills communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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Please note that you should be in your current position for at least 16 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a Partially Meets Expectations or higher. Please visit our Internal Transfer Guidelines for more detailed information
#OperationsEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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.