PD Senior Scientist Biological Relevance and Characterization
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Aug 9, 2019
View more
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
Basic Qualifications
Doctorate degree & 2 years of relevant scientific experience
OR
Master's degree & 4 years of scientific experience
OR
Bachelor's degree & 6 years of scientific experience
Preferred Qualifications:
Expertise in cell 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)
Expertise in virology and oncolytic viruses preferable
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 flow cytometry
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 productively and that adequate resources are projected and selected to accomplish unit responsibilities
Innovation - positive approach to challenges; champions new ideas 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 level; monitors performance and provides adequate feedback through coaching and effective performance appraisal and development planning
Leadership - establishes and implements strategy using an appropriate leadership style; builds teamwork and collaboration
Communication - Excellent written and oral communication skills. 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.
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
Authoring technical reports for investigations, product and impurity characterization, and regulatory submissions
Generates, analyzes, and interprets analytical data to support product development, investigations, and regulatory submissions
Guides resolution of scientific/technical issues
May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by communicating analytical updates, analytical documentation and data
Determines detailed analytical procedures for release, stability, and product characterization testing, including timelines, milestones, methodological approaches, expected results, and necessary resources
Works independently and integrates output into overall project deliverables
May manage a team of lab associates to accomplish project deliverables
Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities and applies this knowledge to the evaluation and development of new methodologies
Recognized as a scientific resource in area of expertise
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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