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Process Development Principal Scientist

Employer
Amgen
Location
Holly Springs, North Carolina
Start date
Jan 31, 2025
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Job Details

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Principal Scientist

What you will do

Lets do this! Lets change the world!

This role is part of Amgens Attribute Sciences (AS) department within the Process Development (PD) organization. We focus on the attributes of our therapies define favorable quality characteristics while optimizing innovative analytical tools.

In this vital role, you will work to provide scientific contributions within Process Development Attribute Sciences at Amgens FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, process development support, and method troubleshooting.

  • Lead the successful completion of technical projects and the development of innovative technologies, serving as a scientific expert and project leader.

  • Collaborate cross-functionally to deliver analytical support for manufacturing and testing.

  • Solve complex problems independently with creativity and ingenuity.

  • Serve as a technical resource for multiple analytical methodologies to assess product quality attributes and process-related impurities, including techniques such as UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR.

  • Evaluate and enhance Amgens platform and analytical technologies to drive innovation and efficiency in Process Development.

  • Present scientific and technical findings effectively in both formal and informal settings.

  • Apply your knowledge of drug development processes to guide project teams and contribute to program strategies.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek is a motivated, self-starter with these qualifications.

Basic Qualifications:

  • Bachelors degree and 7 years of Scientific experience OR

  • Masters degree and 5 years of Scientific experience OR

  • Doctorate degree PhD OR PharmD OR MD and relevant post-doc where applicable and 2 years of Scientific experience.

Preferred Qualifications:

  • Advanced degree in Analytical Chemistry or a biopharmaceutical-related area.

  • Four or more years of experience in pharmaceutical process development, focusing on analytical support, method execution, and drug manufacturing.

  • Expertise in complex analytical problem solving, statistical analysis, and evaluating product quality attributes related to biological processing.

  • Experience in method transfers, validation, troubleshooting, and addressing complex investigations.

  • Strong knowledge of United States Pharmacopeia (USP) monographs and chapters, as well as International Conference on Harmonization (ICH) and FDA guidance.

  • Excellent technical writing skills with strong attention to detail in reports and documentation.

  • Effective communicator who interacts well with diverse internal and external stakeholders and provides cross-functional leadership and mentorship.

  • A proactive team leader, self-starter, and decision-maker with the ability to mentor staff at various levels.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

  • A 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

  • Flexible work models, including remote and hybrid 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

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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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