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Process Development Associate Scientist

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Aug 9, 2019

Job Details

Amgen is seeking a Process Development Associate Scientist - Attribute Sciences to join our team and work from our beautiful Thousand Oaks, CA campus. To learn more about this position: Process Development Associate Scientist - Attribute Sciences

The Attribute Sciences group within Process Development provides scientific and technical expertise to support development and commercialization of Amgen's pipeline of drug candidates. The department identifies and coordinates the achievement of desired product quality attributes towards target product profiles, develops and applies fit-for-purpose analytical methodologies. This position is an exciting opportunity to be a part of Amgen. Our culture encourages open communication to help our staffs to excel throughout their career at Amgen.

The successful candidate will be responsible for providing technical assessments using HPLC, LC/MS, Capillary Electrophoresis (CE) techniques for early phase GMP biologic materials and supporting troubleshooting method related issues, transferring method into an early phase GMP laboratory, and delivering attribute characterization data in a compliance manner. The candidate should have proven skills and extensive experiences in LC, CE, or LC/MS related analytical methods used to test diverse modalities including monoclonal, bispecific antibodies, bispecific T-cell engagers ("BiTEs"), and other protein modalities. This individual will be a part of a team at the interface with early phase and late phase attribute sciences development teams.

Pre-Pivotal Attribute Sciences Scientist Key Responsibilities:
  • Good understanding of cGMP principles and follow compliance requirements in routine day to day work.
  • Technical leadership in support of incoming method transfer/qualification, method optimization, troubleshooting method related issues, and investigations in an early phase GMP environment.
  • Implementing and executing LC/CE and multi-attribute methods as part of the product release testing, stability testing, characterization, method optimization, investigations, and regulatory submissions
  • Documenting all experiments following Good Documentation Practices. Generating, analyzing, and critical evaluation of analytical data to support product release and stability, process characterization, investigations, and regulatory submissions
  • May participate or contribute to critical activities to support analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
  • Provides training and mentoring to junior staff
  • Duties may include managing timelines and resources to delivery to major milestones, participating in process improvement and strategy development .


Basic Qualifications

Master's degree and 2 years of Chemistry, Biochemistry, Chemical Engineering, Molecular Biology related field experience

OR

Bachelor's degree 4 years of Chemistry, Biochemistry, Chemical Engineering, Molecular Biology related field experience

Preferred Qualifications
  • Hands-on experience in developing and implementing methods for clinical products, in-process samples, and process characterization
  • Good understanding of Liquid Chromatography, Capillary Electrophoresis, and/or Mass Spec technologies and strong technical skills in understanding proteins and peptides
  • Strong trouble shooting and critical thinking skills
  • Excellent written and oral communication skills for presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
  • Attention to details and following good documentation practices
  • Experience and ability to perform method qualification/validation and release/stability testing in a fast paced GMP laboratory environment is a plus
  • Works well in teams
  • Knowledge in peptide mapping using LC/MS qualitatively and quantitatively determining protein attributes is a plus
  • Strong computer and organization skills and ability to learn new software quickly and handle stress in a fast-paced environment.
  • Experience in mentoring and managing junior staff and resources is a plus


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 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 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.

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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