Process Development Senior Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Stock-based incentives

Time-off plans

Flexible work models

Job summary

Amgen is seeking a Process Development Senior Scientist in Thousand Oaks, CA. You will join the Pivotal Drug Product Technologies group to advance formulation development for biologics in a fast-paced, cross-functional environment.

The role emphasizes applying analytics, machine learning, and data science to drive formulation improvements, process understanding, and technology transfers for commercial and late-stage products.

Qualifications

• PhD in pharmaceutics or related field with extensive postdoc or industry experience.
• Experience integrating formulation, stability, and analytics for biologics.
• Experience in formulation, fill-finish, tech transfers and SPC.
• Familiar with AI tools and data visualization (Tableau/Spotfire).
• Strong cross-functional collaboration and regulatory submission support.

Responsibilities

• Conduct formulation and process development studies for pipeline products.
• Plan, execute and document development studies with rigorous data analysis.
• Apply statistical and data science methods to inform decisions.
• Develop liquid formulations for biologics and co-formulations.
• Support tech transfer to manufacturing sites and process changes.
• Prepare regulatory sections and technical reports.

Skills

Biologics formulation

Process development

Statistical analysis

Data science / AI tools

Cross-functional collaboration

Regulatory submissions support

Education

PhD/Doctorate

PharmD

MD

Masters + 3 years of experience

Bachelors + 5 years of experience

Tools

Tableau

Spotfire

Programming

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 join Amgens Pivotal Drug Product Technologies group in Thousand Oaks, CA. The group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgens Late-Stage biologics portfolio.

• Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
• Design, plan, complete, and document formulation and process development studies
• Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
• Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
• Develop and characterize liquid formulations for biologics, with particular emphasis on enzyme drug product formulation or co-formulations
• Build process understanding across unit operations to support scalable drug productdevelopment
• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making
• Author/review guideline documents, technical protocols and reports, risk assessments, and regulatory sections in support of IND and marketing application submissions
• Provide support to clinical and commercial technology transfer activities and manufacturing operations through process fit assessments, process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
• Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs
• Lead cross functional initiatives enhancing drug product platforms and contribute to process design improvement projects

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 [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, Chemical Engineering, Bioengineering, Biochemistry, or related field with 24 years of postdoc or industry experience
• Experience integrating formulation, stability, and analytical data to advance biologics including enzyme, mAb and peptide candidates is highly desirable
• Demonstrated understanding of biologics drug product development considerations, including protein stability, degradation pathways, quality attributes, and product/process comparability
• Experience developing or characterizing enzymes, including assessment of activity, stability, and performance under relevant formulation or process conditions
• Experience in formulation and co-formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Strong foundation in analytical and biophysical techniques relevant to biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.)
• Experience with programming, application of AI-enabled tools as well as data visualization tools (e.g. Tableau, Spotfire)
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs)
• Strong project management skills, including the ability to manage ones project resources (material, workforce, time, etc.)
• Critical thinking, problem solving and independent research skills
• Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally

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.

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.

Equal Opportunity

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.