Process Development Senior Scientist

Amgen Inc.; Thousand Oaks (CA); On-site; USD 126,000 - 171,000; Full time

Job summary

Amgen Inc. in Thousand Oaks, CA, is seeking a Process Development Senior Scientist to join the Pivotal Drug Product Technologies group.

You will drive formulation and process development for biologics, with emphasis on enzymes, mAbs, and peptides, integrating data across formulation, analytics, and manufacturing to deliver stable, manufacturable products. The role requires strong CQAs knowledge, proficiency with analytical techniques, and experience with AI-enabled tools.

Qualifications

• Doctorate degree PhD OR PharmD OR MD [and relevant post‑doc where applicable]
• Master’s degree and 3 years of Scientific experience
• Bachelor’s degree and 5 years of Scientific experience
• PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or related field with 2–4 years of postdoc or industry experience
• Experience integrating formulation, stability, and analytical data for biologics including enzymes, mAbs and peptides
• Knowledge of protein stability, degradation pathways, quality attributes, and product/process comparability
• Experience with enzymes and formulation/co‑formulation development, fill‑finish process engineering, tech transfers
• Strong analytical and biophysical techniques (UPLC/HPLC, SEC, IEX, RP‑HPLC, HIC, CE‑SDS, subvisible particles)
• Programming and AI-enabled tools; data visualization (Tableau, Spotfire)
• Regulatory submissions experience (CTAs, BLAs) and cross‑functional collaboration
• Strong project management and ability to manage resources; independent research skills
• Ability to operate in fast-paced matrix environments

Responsibilities

• Participate in Drug Product Commercialization Teams for development and lifecycle support
• Design, plan, complete, and document formulation and process development studies
• Apply principles to develop and implement processes and next‑gen technologies
• Apply advanced statistical/data analytics to inform decisions
• Develop and characterize liquid biologics formulations, incl. co‑formulations
• Build process understanding across unit operations for scalable development
• Apply machine learning, AI, and data science to predictive modeling and workflows
• Author/review guidelines, protocols, reports, risk assessments, regulatory sections
• Support technology transfer and manufacturing through analyses and investigations
• Stay current with industry advances to meet future business needs
• Communicate progress to management and cross‑functional partners
• Lead cross‑functional initiatives to enhance drug product platforms

Skills

Analytical thinking

Programming

AI/ML familiarity

Communication

Education

PhD/PharmD/MD

Master’s with 3 years scientific experience

Bachelor’s with 5 years scientific experience

PhD in Pharmaceutics or related field

Tools

UPLC/HPLC

SEC

IEX

RP-HPLC

HIC

CE-SDS

Tableau/Spotfire

Job 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity‑related conditions, rare diseases, inflammatory conditions and cancer. 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 Senior Scientist

Let’s do this. Let’s change the world. In this vital role you will join Amgen’s Pivotal Drug Product Technologies group in Thousand Oaks, CA. The group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen’s Late‑Stage biologics portfolio.

The ideal candidate will bring hands‑on experience in biologics drug product formulation and co‑formulation, with experience across multiple modalities, including enzymes, monoclonal antibodies (mAbs), and peptides. The candidate will have a strong understanding of protein attributes, stability and process‑related degradation pathways, and analytical strategies for characterizing critical quality attributes (CQAs). This role will integrate formulation, analytical, and process data to guide product design and development. The successful candidate will apply innovative technologies, including AI and machine learning where appropriate, and collaborate across functions to deliver high‑quality, stable, and manufacturable drug products in a fast‑paced environment.

What you will do

• Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
• Design, plan, complete, and document formulation and process development studies
• Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
• Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
• Develop and characterize liquid formulations for biologics, with particular emphasis on enzyme drug product formulation or co‑formulations
• Build process understanding across unit operations to support scalable drug product development
• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision‑making
• Author/review guideline documents, technical protocols and reports, risk assessments, and regulatory sections in support of IND and marketing application submissions
• Provide support to clinical and commercial technology transfer activities and manufacturing operations through process fit assessments, process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non‑conformance investigations
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
• Effectively and consistently communicate with management, cross‑functional partners and relevant team members on progress towards achievements and forthcoming program needs
• Lead cross functional initiatives enhancing drug product platforms and contribute to process design improvement projects

What we expect of you

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

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD [and relevant post‑doc where applicable]
• OR
• Master’s degree and 3 years of Scientific experience
• OR
• Bachelor’s degree and 5 years of Scientific experience

Preferred Qualifications:

• PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or related field with 2–4 years of postdoc or industry experience
• Experience integrating formulation, stability, and analytical data to advance biologics including enzyme, mAb and peptide candidates is highly desirable
• Demonstrated understanding of biologics drug product development considerations, including protein stability, degradation pathways, quality attributes, and product/process comparability
• Experience developing or characterizing enzymes, including assessment of activity, stability, and performance under relevant formulation or process conditions
• Experience in formulation and co‑formulation development, fill‑finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Strong foundation in analytical and biophysical techniques relevant to biologics (e.g., UPLC/HPLC, SEC, IEX, RP‑HPLC, HIC, CE‑SDS, subvisible particle analysis, etc.)
• Experience with programming, application of AI‑enabled tools as well as data visualization tools (e.g. Tableau, Spotfire)
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs)
• Strong project management skills, including the ability to manage one’s project resources (material, workforce, time, etc.)
• Critical thinking, problem solving and independent research skills
• Strong ability to operate well in a fast‑paced, matrixed environment and collaborate successfully cross‑functionally

What you can expect of us

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Salary Range

126,066.05USD -170,559.95 USD

Sponsorship

Sponsorship for this role is not guaranteed.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

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