Process Development - Senior Scientist

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 - Senior Scientist

What you will do

Lets do this! Lets change the world!

Amgen is currently seeking a Process Development Senior Scientist in our Pre-Pivotal Attribute Sciences Department in Thousand Oaks, CA. Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the critical quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pre-Pivotal AS organizations focus is on supporting analytical method development and product characterization to advance candidates from research to first-in-human (FIH) clinical trials.

The Process Development Senior Scientist will contribute to Amgens diverse early-stage portfolio of therapeutic modalities with a focus on understanding process and product properties of large molecule drug candidates and assessing the product quality attributes of biotherapeutics being developed across multiple therapeutic areas in Amgens pipeline. The candidate will be responsible for analytical leadership of pre-pivotal programs and the implementation of sophisticated analytical techniques to characterize novel modalities in the pipeline.

Key Responsibilities

• Serve as Attribute Sciences Team/Technical Lead (ASTL) to support lead molecule selection and development through FIH clinical trials

• Independently design and execute experiments to gain fundamental understanding of product quality attributes and stability characteristics of biotherapeutics

• Develop and optimize analytical methods (e.g. HPLC/UHPLC, CE) to ensure method performance, reliability, efficiency, and sustainability

• Support drug substance and drug product process development by providing technical and strategic input

• Develop and deploy in silico analysis and data science platforms to enhance attribute understanding, consolidate data, and enable generation of cross product insights

• Effectively communicate with key stakeholders from peers to senior management across functions through presentations and written communications

• Coordinate technology transfer with internal and external partners to ensure proper control strategies and regulatory compliance

• Author regulatory documents and understand expectations for analytical methods, control and stability strategy, and comparability

• Actively collaborate with cross-functional partners in Research, Process Development, Product Quality, and Manufacturing to drive innovation and continuous improvement

• Engage with industry, academia, and regulatory authorities through publications, conferences, and participation in consortia to stay current with and shape emerging analytical technology, attribute understanding, and data science approaches

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 an individual with these qualifications.

Basic Qualifications:

• Bachelors degree and 5 years of Scientific experience OR

• Masters degree and 3 years of Scientific experience OR

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

Preferred Qualifications:

• Ph.D. in biochemistry, biophysics, bioengineering, chemistry, or other life science areas plus 2 or more years of industry experience

• Strong lab skills to design and execute scientific experiments with high safety standards and ability to be resourceful and creative

• Strong foundation in data analysis and interpretation, with the ability to communicate complex technical results to both technical and non-technical audiences

• Expertise in analytical method development, validation, and troubleshooting for using HPLC/UHPLC, CE

• Proven experience in separation sciences, protein chemistry, and biochemistry

• Proficiency in programming, bioinformatics, artificial intelligence tools, and building user friendly workflows and visualization tools

• Familiarity with commonly observed product quality attributes associated with therapeutic proteins (e.g. aggregation, fragmentation, deamidation, oxidation, partial reduction, glycosylation), and their enrichment (e.g. physicochemical stress, fractionation, enzymatic processing), characterization, and quantification tools

• Prior experience with authoring or contributing to regulatory filings

• Team player who can also work independently to advance projects within required deadlines

• Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary environment

What you can expect from 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 and make a lasting impact with the Amgen team.

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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. 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.

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