Process Development Senior Scientist - Drug Product Technologies

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

Benefits offered by this job

Retirement and Savings Plan

Medical, dental, and vision coverage

Disability insurance

Stock-based long-term incentives

Flexible time-off

Job summary

Amgen Inc. in Thousand Oaks seeks a Process Development Senior Scientist to advance drug product technologies for biologics, with emphasis on ADC formulation, stability, and scalable processes. You will collaborate across functions and apply data science to improve development decisions.

The ideal candidate brings deep formulation and analytical experience, strong communication skills, and a track record in regulatory support and tech transfer.

Qualifications

• PhD, PharmD, or MD (or Master’s with 3+ years scientific experience) in related field.
• Preferred PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 2–4 years postdoc/industry experience.
• Experience in formulation development, stability testing, and fill/finish for biologics; ADC DP formulation preferred.

Responsibilities

• Collaborate across process development, research, regulatory, and manufacturing teams.
• Plan and execute formulation and fill/finish studies for early-stage programs.
• Develop and characterize liquid and lyophilized formulations for biologics, esp. ADC DP.
• Build process understanding across unit operations for scalable DP development.
• Evaluate in-use compatibility and DP stability under clinical conditions.
• Apply AI/ML to predictive modeling and workflow acceleration.
• Support tech transfer activities with CMOs/CDMOs and batch reviews.

Skills

Formulation development

Stability testing

AI/ML in R&D

Regulatory submissions

Communication skills

Education

PhD, PharmD, or MD

Master’s degree with 3+ years experience

Bachelor’s degree with 5 years experience

Tools

UPLC/HPLC

SEC

IEX

RP-HPLC

HIC

CE-SDS

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. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 - Drug Product Technologies

What you will do

Let’s do this. Let’s change the world.

• Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.
• Plan and execute formulation and fill/finish process studies for early-stage programs.
• Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab-scale sterile filling.
• Build process understanding across unit operations to support scalable drug product development.
• Evaluate in-use compatibility and drug product stability under clinical conditions.
• Investigate ADC- and biologics-relevant CQAs (e.g., aggregation, fragmentation, drug-to-antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.
• Leverage high-throughput tools for formulation screening and processability assessments.
• Identify and address technology gaps impacting ADC stability, linker-payload integrity, protein-excipient interactions, and process-related stress responses.
• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making.
• Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing.
• Author technical documents, control‑strategy inputs, risk assessments, IND/CTA regulatory sections, and tech transfer packages.
• Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and troubleshooting during manufacturing campaigns.
• Present findings to internal/external stakeholders and participate in cross‑functional teams.

What we expect of you

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, Biochemistry, or related field with 2-4 years of postdoc or industry experience.
• Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience is strongly preferred.
• Demonstrated understanding of ADC drug product development considerations, including linker‑payload stability, drug-to-antibody ratio, free drug or payload degradation, quality attributes, and product/process comparability.
• Experience integrating formulation, stability, and analytical data to advance ADC candidates from discovery or preclinical development into clinical manufacturing is highly desirable.
• Strong foundation in analytical and biophysical techniques relevant to ADCs and biologics (e.g., UPLC/HPLC, SEC, IEX, RP‑HPLC, HIC, CE‑SDS, subvisible particle analysis, etc.).
• Familiarity with clinical-stage development, manufacturability, and risk‑based decision‑making.
• Experience applying AI/ML (e.g., LLMs, in silico tools) to streamline R&D and optimize performance.
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs).

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.

Salary Range 126,066.05USD -170,559.95 USD

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.

Sponsorship for this role is not guaranteed.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen