Process Development Senior Principal Scientist

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.

Process Development Senior Principal Scientist

Lets do this. Lets change the this vital role you will join our Pivotal Drug Product Technologies group in Thousand Oaks CA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgens Late-Stage biologics.

The Senior Principal Scientist will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process.

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 developmentin a fast-paced environment.

• Lead planning design execution and documentation of laboratory studies related to drug product design formulation and process development and tech transfer

• Deliver progress reports and presentations to ensure management awareness and engagement of the status progress and future program and functional needs

• Author and review guideline documents technical protocols reports product impact assessments regulatory submissions and developing responses to regulatory questions

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

• Lead internal and external technology transfer activities including collaboration with CMOs/CDMOs process fit assessments and troubleshooting during manufacturing campaigns.

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

• Serve as a Drug Product Team Lead of a matrixed team to develop strategy in support of commercialization and life cycle management of Amgens pipeline

• Manage team of engineers and scientists to advance program and functional objectives

• Work effectively in a highly matrixed team environment to influence and inspire change efficiency and foster positive relationships

• Ability to travel domestically and internationally up to 10% of the time

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 2 years of Scientific experience
OR
Masters degree and 5 years of Scientific experience
OR
Bachelors degree and 7 years of Scientific experience

Preferred Qualifications:

• Advanced degree in Engineering Pharmaceutics Biotechnology Material Science or related subject area

• 8 years of experience in pharmaceuticals/biotechnology

• 5 years of experience that includes elements of formulation and fill/finish process development process characterization technical transfers to manufacturing sites and statistical design and analysis of experiments and regulatory authoring

• 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 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.).

• Technical leader with demonstrated results driving forward programs

• Experience in drug product regulatory strategy RTQs and agency engagement

• Knowledge of and hands-on experience with bringing new biotech products to market across various dosage forms and device delivery systems

• Experience with programming (e.g. Python R MATLAB) and database languages (e.g.

• SQL) as well as data visualization tools (e.g. Tableau Spotfire D3js)

• Proficiency in at least one statistical software package (e.g. SAS JMP or Minitab)

• Experience participating and leading global multi-functional teams

• Outstanding knowledge of formulation aseptic processing and manufacturing of biotechnology products vials syringes cartridges devices disposables modeling and the associated GMP/Device documentation and regulatory filings

• Strong problem solving and effective multi-functional interpersonal skills

• Willing and able to learn new technologies at a rapid pace

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