Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies

Amgen SA; Thousand Oaks (CA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Competitive benefits

Stock-based incentives

Flexible work models where possible

Job summary

Amgen in Thousand Oaks, CA seeks a Process Development Sr Scientist to lead early- and mid-stage formulation and fill/finish development for biologics. You will design robust, scalable processes, evaluate CQAs, and partner with automation and data science teams to accelerate programs.

You will implement high-throughput screening, DoE, and lab automation to improve throughput and data quality, contributing to regulatory submissions and technology transfer.

Qualifications

• Doctorate or PharmD/MD with scientific experience in formulation development.
• Proven experience in biologics formulation and fill/finish operations.
• Understanding of CQAs, stability, and protein-excipient interactions.
• Experience in high-throughput formulation screening and DoE.
• Background in lab automation, robotic workflows, and data capture.
• Familiarity with regulatory submissions and tech transfer.
• Strong collaboration across cross-functional teams.
• Ability to prioritize and manage multiple programs.

Responsibilities

• Lead early/mid-stage formulation development for biologics and processes.
• Design robust, scalable fill/finish processes with quality attributes in mind.
• Collaborate with automation, data science, and regulatory teams.
• Plan and execute high-throughput screening and DoE studies.
• Develop and characterize liquid and lyophilized formulations.
• Build process understanding across unit operations for scalability.
• Contribute to regulatory submissions and technology transfer activities.
• Present findings to stakeholders and cross-functional teams.

Skills

High-throughput formulation

Biologics drug product formulation

Lab automation & robotics

Education

PhD in Pharmaceutics/Biochemistry/Biology

MS with 3+ years scientific experience

BS with 5+ years scientific experience

Tools

Hamilton liquid handling

Tecan platforms

Beckman Coulter systems

Opentrons

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 Sr Scientist

What you will do

Let’s do this. Let’s change the world. In this vital role you will join Pre-Pivotal Drug Product Technologies group, responsible for early-stage drug product development across diverse modalities, with a strong emphasis on monoclonal antibodies,multispecificsandotherbiologicmodalities. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs);establishingrobust, scalable fill/finish processes for complex biologic drug products; and authoringand supportinghigh quality regulatory submissions.

• 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 liquidandlyophilizedformulations for biologics, with particular emphasis on biologics drug product formulation, handling, and lab-scale sterile filling.

• Build process understanding across unit operations to support scalable drug productdevelopment.

• Evaluate in-use compatibility and drug product stability under clinical conditions.

• Investigate biologics-relevant CQAs (e.g., aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions) to inform formulation and processdesigndecisions.

• Design, develop, and execute automated high-throughput formulation screening workflows to accelerate excipient selection, formulation optimization, and processability assessments.

• Develop and implement laboratory automation solutions, including robotic liquid handling systems and automated sample preparation workflows, to improve experimental throughput, reproducibility, and data quality.

• Partner with automation engineers, data scientists, and digital teams to deploy integrated automated workflows that support formulation development, stability studies, and process characterization.

• Utilize design of experiments (DoE), high-throughput experimentation, and automated data analysis pipelines to efficiently explore formulation design space and support data-driven decision making.

• Identifyand address technology gapsimpactingbiologics stability, protein-excipient interactions, and process-related stress responses.

• Apply machine learning, AI, laboratory automation, and advanced data science to predictive modeling, workflow acceleration, and decision-making.

• Ensure development approaches arephase-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

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
OR
Master’s degree and 3 years of Scientific experience
OR
Bachelor’s degree and 5 years of Scientific experience

Preferred Qualifications

• Requirement 1 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 biologics drug product formulation experience is strongly preferred.

• Demonstrated understanding of biologics drug product development considerations, including protein degradation, quality attributes, and product/process comparability.

• Experience integrating formulation, stability, and analytical data to advance biologics candidates from discovery or preclinical development into clinical manufacturing is highly desirable.

• Hands-on experience with high-throughput formulation development, automated liquid handling systems (e.g., Hamilton, Tecan, Beckman Coulter, Opentrons, or equivalent), and robotic laboratory workflows.

• Experience designing and executing high-throughput formulation screening studies for biologics, including automated preparation, analytical characterization, and data analysis.

• Experience implementing laboratory automation, workflow digitization, and electronic data capture to improve R&D productivity.

• Familiarity with DoE, high-throughput experimentation, laboratory robotics, and workflow orchestration for formulation and process development.

• Strong foundation in analytical and biophysical techniques relevant to biologics 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 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, 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.