Process Development Principal Scientist – Drug Product Technologies

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets change the this vital role you will join the Pre-Pivotal Drug Product Technologies group which is responsible for early-stage drug product development across diverse modalities including antibody-drug conjugates (ADCs) oligonucleotides such as siRNAs monoclonal antibodies multispecifics and other complex biologics. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs); establishing robust scalable fill/finish processes; and authoring and supporting high-quality regulatory submissions.

The ideal candidate will bring hands-on experience and leadership in biologics drug product formulation process development and/or analytical characterization with experience in ADCs and/or oligonucleotides such as siRNAs strongly preferred. The candidate will integrate formulation analytical stability and process data to guide product design and development including modality-specific considerations such as linker-payload attributes stability- and process-relevant degradation pathways ADC CQAs oligonucleotide formulation and stability considerations and phase-appropriate analytical strategies. This individual will apply scientific judgment emerging technologies including AI/ML and strong cross-functional collaboration to deliver high-quality stable and manufacturable drug products for clinical development in a fast-paced environment.

Serve as a leader on Drug Product teams responsible for planning designing executing and documenting laboratory studies related to drug product design formulation process development technology transfer and regulatory authoring in support of advancing Amgens diverse biologics pipeline.

Work effectively in a fast-paced matrixed environment collaborating across process development research analytical regulatory quality manufacturing and external partner teams to advance programs influence development strategies and communicate technical recommendations to scientific peers and leadership.

Develop and characterize liquid and lyophilized formulations for complex biologics including ADCs oligonucleotides monoclonal antibodies multispecifics and other emerging modalities.

Build process understanding across unit operations to support scalable drugproductdevelopment.

Evaluate in-use compatibility and drug product stability under clinically relevant conditions.

Investigate biologics- and modality-relevant CQAs including aggregation fragmentation charge and size variants subvisible particles surface interactions concentration-dependent behavior and where applicable ADC- or oligonucleotide-specific attributes such as drug-to-antibody ratio free payload linker-payload integrity and oligonucleotide purity or degradation pathways.

Leverage high-throughput and data-driven tools for formulation screening stability assessment developability evaluation and processability characterization.

Identify and address technology gaps impacting drug product stability manufacturability excipient interactions modality-specific degradation pathways and process-related stress responses.

Apply machine learning AI automation and data science approaches to predictive modeling workflow acceleration data integration and decision-making.

Drive continuous improvement in drug product development through scientific innovation platform approaches first-principles thinking and the adoption of new technologies and standardized methodologies.

Ensure development approachesarephase-appropriatefromdiscovery through clinical manufacturing.

Provide scientific and technical expertise and leadership in biologics drug product development serving as a subject matter expert for formulation stability process development and modality-specific considerations for ADCs oligonucleotides and other complex biologics.

Define and influence drug product development strategies across programs by identifying key risks recommending phase-appropriate studies and integrating formulation analytical process manufacturability and regulatory considerations into program decisions.

Serve as a recognized scientific resource within area of expertise providing technical guidance mentorship and coaching to junior scientists and cross-functional team members.

Author and review technical documents formulation and process development reports control-strategy inputs risk assessments IND/CTA regulatory sections and technology 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.

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

Basic Qualifications:

Doctorate degree
OR
Masters degree and 2 years of Scientific experience
OR
Bachelors degree and 4 years of Scientific experience

Preferred Qualifications:

PhD in Pharmaceutics Biotechnology Biochemistry Chemical Engineering Pharmaceutical Sciences or a related field with 3 years of relevant industry experience.

Proven experience in biologics drug product formulation development stability assessment process development and/or fill/finish operations; direct experience with ADCs oligonucleotides such as siRNAs or other complex biologic modalities is strongly preferred.

Demonstrated understanding of drug product development considerations for biologics and complex modalities including formulation stability degradation pathways aggregation particulates manufacturability product/process comparability and phase-appropriate control strategies.

Experience with ADC drug product development considerations including linker-payload stability drug-to-antibody ratio free drug or payload-related impurities ADC-relevant quality attributes and process-related stress responses is highly desirable.

Experience with oligonucleotide or siRNA drug product development considerations including formulation stability degradation pathways excipient compatibility analytical characterization and clinical administration considerations is highly desirable.

Experience integrating formulation stability analytical and process data to advance drug product candidates from discovery or preclinical development into clinical manufacturing.

Strong foundation in analytical and biophysical techniques relevant to biologics ADCs and/or oligonucleotides such as UPLC/HPLC SEC IEX RP-HPLC HIC CE-SDS LC-MS subvisible particle analysis viscosity osmolality and stability-indicating methods.

Familiarity with clinical-stage development manufacturability technology transfer and risk-based decision-making.

Experience applying AI/ML automation LLMs in silico tools or data science approaches to streamline R&D workflows improve data integration and support decision-making.

Skilled communicator with experience authoring technical reports and contributing to regulatory submissions including INDs CTAs BLAs or equivalent global filings.

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 well 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.

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.

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 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.

Salary Range