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Process Development Principal Scientist - Cellular Sciences

Employer
Amgen
Location
Thousand Oaks, California
Start date
Feb 14, 2024

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Process Development Principal Scientist

Live

What you will do

Lets do this! Lets change the world!

The Amgen Thousand Oaks Cellular Sciences department is seeking an enthusiastic, highly motivated, and team-oriented scientist for the position of Process Development Principal Scientist, to join and lead our Cellular Sciences group. The Principal Scientist will provide scientific, technical and managerial leadership in support of Cellular Sciences key responsibilities which include:

  • Ensuring Viral Safety of biotechnology derived therapeutics by performing Viral Clearance Assessments for clinical and commercial programs

  • Technology development to further and streamline Viral Clearance Assessments

  • Evaluation and Development of groundbreaking technologies for detection and identification of adventitious agents of any type, i.e. viruses, bacteria, mycoplasma, fungi or protozoa arising from a variety of substrates including process raw materials and environmental samples

  • Technology development, process troubleshooting, as well as qualification and validation of such technologies for use in commercial and clinical manufacturing contamination investigations

  • Regulatory Support for issues related to adventitious agents

  • Mitigation of adventitious agent contamination risk

Reporting to the Director of Cellular Sciences, the Principal Scientist will manage a team of scientists and associates and contribute to the strategic direction of the group based on industry trends, future requirements and feedback from key partners as well as regulatory requirements.

Job Summary:
  • Leads a high performing technical team with diverse scientific disciplines

  • Will effectively work with partners in Process Development, Quality and Regulatory to align on activities in all development stages and compliance

  • Takes a proactive role in identifying current advances and trends in detection and identification methods for adventitious agents

  • Advance the organizations acumen on phase appropriate GMP compliance and current regulatory trends and expectations

  • Guide and mentor others on day-to-day performance, long term career development and through change

  • Organize and Leverage resources to improve output while still being very innovative

  • Build and maintains strong working relationships with relevant internal and external customers and partners

  • Executes with a sense of purpose and drives course corrections where appropriate

  • Contributes to regulatory filings, including IND and BLA; as needed assists in answering questions from regulatory authorities

  • Support thorough review of department scientific and regulatory deliverables

  • Recruit and retain highly capable staff that can deliver in a highly matrixed and dynamic environment

In our mission to serve patients, speed is absolutely critical. Were rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team working toward our mission of advancing high potential programs for cancer patients around the world.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek is an employee with these qualifications.

Basic Qualifications:

Doctorate degree and 3 years of scientific experience Or

Masters degree and 6 years of scientific experience Or

Bachelors degree and 8 years of scientific experience

Preferred Qualifications:
  • Master's or PhD in Virology or Microbiology with extensive experience in molecular biology

  • 3+ years industrial experience in the area of safety of biotechnology derived therapeutics from adventitious agents with an emphasis on viral safety

  • Experienced in managing diverse scientific teams with skills to leverage and develop staff's potential in a fast-paced data driven organization

  • Well versed in, and with demonstrated and extensive hands-on experience with general cell and molecular biology techniques such as cell culture maintenance, in vitro viral infections, nucleic acid isolation, cloning techniques, and advanced PCR methodologies

  • Familiar with current advances and trends in detection and identification methods for adventitious agents as they relate to production of protein therapeutics in mammalian cell culture systems

  • Advanced scientific/technical reading/writing skills, advanced scientific analysis skills, and advanced laboratory work skills

  • Demonstrated problem solving ability and strong oral and written communication skills.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

  • Stock-based long-term incentives

  • Award-winning time-off plans and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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 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 accommodation.

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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