Process Development Sr Associate

Amgen Inc.•Thousand Oaks, CA

77d

About The Position

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 Sr Associate What you will do Let's do this! Let's change the world! Based in Thousand Oaks, CA, the role of Process Development Sr Associate in Pivotal Drug Product Technologies will support Amgen's large molecule drug product formulation and fill/finish process development. The Sr Associate 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, visualization tools, leveraging emerging AI and GenAI tools to accelerate insights, optimize process development, and enable smarter decision-making.

Requirements

High school diploma / GED and 6 years of Scientific experience OR
Associate's degree and 4 years of Scientific experience OR
Bachelor's degree and 2 years of Scientific experience OR
Master's degree

Nice To Haves

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.
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.

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.

Benefits

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 where possible.

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