Process Development Senior Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Paid time off

Job summary

Amgen is seeking a Process Development Senior Scientist to lead drug product development for oral solid dosage forms and to influence strategy across IND-enabling studies and GMP clinical manufacturing. You will design robust formulations, oversee scale‑up, and drive technology transfer with internal and external partners.

The role emphasizes cross‑functional collaboration, regulatory documentation, and advancing next‑generation delivery capabilities in oncology and related areas.

Qualifications

• PhD/PharmD/MD with post‑doc or equivalent experience.
• Masters with 3 years scientific experience or Bachelor with 5 years experience.

Responsibilities

• Lead drug product development strategy for early clinical programs.
• Design and execute formulation and process development experiments for oral solids.
• Collaborate with internal/external partners for scale‑up and GMP manufacturing.
• Prepare and review INDs, CTAs, and related CMC submissions.
• Present strategies and risk assessments to cross‑functional teams.

Skills

Drug product development

Cross-functional collaboration

Regulatory documentation

Analytical thinking

Education

PhD in Pharmaceutical Sciences or related field

MD/PharmD considered

Tools

HME

SSD

Process scale-up

Job description

Join Amgens Mission of Serving Patients
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 Scientist

What you will do

Lets do this. Lets change the world. In this vital role you will have the opportunity to work on complex synthetic molecule platforms, including targeted protein degraders, PROteolysis TArgeting Chimeras (PROTACs), molecular glues, and other beyond-rule-of-5 compounds with challenging physicochemical and biopharmaceutical properties.

The scientist will primarily design and execute formulation and process development studies for oral solid dosage forms, ranging from conventional oral solid dosage formulations to advanced enabling formulation strategies intended to overcome solubility, dissolution, absorption, and bioavailability limitations. The scientist will develop robust, scalable, and phase-appropriate formulations suitable for IND-enabling studies and GMP clinical manufacturing.

This role provides significant opportunity to influence drug product strategy and advance next-generation oral delivery capabilities across Amgens synthetic molecule portfolio.

The individual will work closely with internal manufacturing and external manufacturing partners to support process scale-up, GMP clinical manufacturing, technology transfer, and regulatory submissions. The scientist may support multiple fast-paced programs across oncology and other therapeutic areas with varying molecular and formulation complexities.

Key Responsibilities

• Serve as the Drug Product Team Lead and primary Drug Product functional representative on cross-functional synthetic molecule development teams
• Independently lead drug product development strategy and execution for early clinical synthetic molecule programs
• Lead and execute drug product development activities with a focus on right-first-time delivery, proactive risk management, and on-time achievement of program milestones.
• Design and execute formulation and process development experiments for oral solid dosage forms, including platform and enabling formulations
• Apply scientific understanding of material properties, biopharmaceutics, and manufacturability to formulation strategy selection and process development
• Identify technical risks, develop mitigation strategies, and drive solutions to support program timelines and clinical objectives
• Partner effectively across internal functions and external CMOs to support program execution, technology transfer, scale-up, and GMP clinical manufacturing
• Author and review technical and regulatory documentation including INDs, CTAs and related CMC submissions
• Present technical strategies, development plans, risks, and recommendations to cross-functional teams and governance forums
• Contribute to continuous improvement initiatives and advancement of formulation and process development capabilities

What we expect of you

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

• Ph.D. in Pharmaceutical Sciences, Bioengineering, Chemical Engineering, Chemistry, or related scientific discipline with emphasis on oral drug product development for advanced synthetic modalities including degraders and PROTACs.
• Industry experience supporting early clinical drug product development programs preferred.
• Hands-on experience with enabling solubility formulation technologies including hot melt extrusion (HME), spray dried dispersions (SDD), and downstream processing for oral solid dosage forms.
• Experience supporting oral solid dosage form process development, scale-up, technology transfer, and GMP clinical manufacturing.
• Strong understanding of formulation development for poorly soluble compounds and enabling bioavailability enhancement strategies.
• Experience serving as a Drug Product or Formulation Development representative on interdisciplinary and multidisciplinary teams.
• Experience authoring regulatory documentation including INDs, CTAs, and related RTQs.
• Excellent interpersonal and verbal/written communication skills with demonstrated ability to manage complex cross-functional project activities.

What You Can Expect Of 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, 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.

careers.amgen.com

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.

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.