Process Development Associate Scientist - Attribute Sciences

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Company: Amgen Inc

Location: Thousand Oaks, CA 91360

Description:

Career Category
Scientific
Job Description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Associate Scientist - Attribute Science

What you will do

Let's do this! Let's change the world!

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.

Amgen's Pre-Pivotal Attribute Sciences group in Thousand Oaks, California is seeking an Associate Scientist. The successful candidate will be responsible for providing technical assessments using HPLC and 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 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 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 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 .


What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a individual with these qualifications.

Basic Qualifications:
  • Bachelor's degree and 3 years of Scientific experience OR
  • Master's degree and 1 year of Scientific 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 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 digital tools or automation 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.


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, we'll 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 and make a lasting impact with the Amgen team.

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.

Salary Range
96,605.00 USD - 119,055.00 USD

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