Process Development Senior 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 Pre-Pivotal Drug Product Technologies group responsible for early-stage drug product development across diverse modalities with a strong emphasis on antibody-drug conjugates (ADCs) as well as monoclonal antibodiesmultispecificsandotherbiologicmodalities. 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.

The ideal candidate will bring hands-on experience in ADC drug product formulation anddrug product process development includinga mechanisticunderstanding of linker-payload attributesstability/process-relevant degradation pathways and analytical strategies used to characterize ADCCQAs. This candidate will integrate formulation analytical and process data to guide product designapplycutting-edgetechnologies (including AI/ML) and collaborate cross-functionally to deliver high-quality stable and manufacturable drug products for clinical developmentin a fast-paced environment.

Key Responsibilities

• 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 ADC 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 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 processdesigndecisions.
• Leverage high-throughput tools for formulation screening and processability assessments.
• Identifyand address technology gapsimpactingADC 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 arephase-appropriatefrom 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.

We are all different yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD and relevant post-doc where applicable
• OR
• Masters degree and 3 years of Scientific experience
• OR
• Bachelors degree and 5 years of Scientific experience

Preferred Qualifications:

• PhD in Pharmaceutics Biotechnology Biochemistry or related field with 24 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 payloaddegradation 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 foundationin 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 andoptimizeperformance.
• Skilled communicator with experience contributing to regulatory submissions (CTAs BLAs).

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