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PD Senior Scientist Biological Relevance and Characterization

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Oct 8, 2019

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Discipline
Science/R&D, Biotechnology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details

Amgen is seeking a Process Development Senior Scientist Biological Relevance and Characterization to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:

This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions.

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

Basic Qualifications:

Doctorate degree and 2 years of relevant scientific experience

OR

Master's degree and 5 years of scientific experience

OR

Bachelor's degree & and 7 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.

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs 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.

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.

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.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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