Process Development Associate Scientist Full-time NEW

Process Development Associate Scientist

Join Amgen's mission of serving patients. 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.

Based in Thousand Oaks, CA, the role of Process Development Associate Scientist in Pivotal Drug Product Technologies will support Amgen's large molecule drug product formulation and fill/finish process development. The Associate Scientist will perform formulation studies, evaluate the impact of process stresses on drug product attributes and stability, and define process parameters for fill/finish unit operations. This role will also focus on advanced data analytics, statistical modeling, and visualization, leveraging emerging AI and GenAI tools to accelerate insights, optimize process development, and enable smarter decision-making.

Responsibilities:

• Plan, design, execute, and document studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics (antibodies, BiTEs, proteins, viruses, RNA).
• Perform analytical characterization supporting formulation and stability assessments using chromatography and biophysical tools (SE-HPLC, CE-SDS, DSC, NMR, HIAC).
• Author and review technical protocols, reports, product impact assessments, and regulatory sections for IND and marketing application submissions.
• Apply advanced information systems to improve drug product design by integrating historical data, analyzing large datasets, and performing statistical analysis.
• Create effective data visualizations and use AI/GenAI-driven approaches to generate automated insights, predictive models, and interactive dashboards.
• Explore and evaluate new digital tools to enhance team capabilities in process development and operations.
• Support clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for investigations and changes.
• Contribute to the standardization and optimization of departmental practices by developing and improving guideline documents.
• Deliver progress reports and presentations to ensure management engagement and alignment.

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 collaborator with these qualifications:

• Bachelor's degree and 3 years of scientific experience OR
• Master's degree and 1 year of scientific experience

Preferred Qualifications:

• Master's degree in Pharmaceutics, Biotechnology, Engineering, Material Science, or related discipline.
• 2+ years of experience in pharmaceuticals/biotechnology, including new product development, process characterization, formulation, technology transfer, and statistical analysis of experiments.
• Experience with drug product formulation and fill/finish unit operations (freeze/thaw, formulation, mixing, filtration, filling, inspection).
• Strong understanding of protein stability and the impact of process stresses on product quality; experience with RNA or virus modalities is a plus.
• Proficiency in statistical software (e.g., SIMCA, JMP).
• Expertise in data visualization tools (e.g., Tableau, Spotfire) and coding/scripting for automated data analysis and modeling.
• Demonstrated use of AI/GenAI for data visualization, predictive modeling, anomaly detection, and workflow automation in process development.
• Aseptic processing experience and familiarity with cGMPs.
• Experience with regulatory filings and compliance for sterile injectable products.
• Strong problem-solving, cross-functional communication skills, and ability to act on dynamic information at a rapid pace.

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.