Process Development Sr Scientist

Amgen SA; Thousand Oaks (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Amgen is seeking a Process Development Senior Scientist to design and execute bench-scale drug substance processes across cell culture and purification operations.

You will apply platform approaches, solve challenges, and contribute to technology development while expanding skills in cell culture and purification within a cGMP environment. Collaboration with analytical and drug product teams is essential.

Qualifications

• Doctorate in a STEM field or equivalent.
• Demonstrated bioprocess development and scale-up experience.
• Strong cell culture and purification knowledge.
• GMP/cGMP manufacturing experience preferred.
• Proven ability to analyze data and communicate results.

Responsibilities

• Design and execute bench-scale drug substance processes.
• Apply platform approaches and solve day-to-day challenges.
• Drive innovation and contribute to technology development.
• Expand skills in cell culture and purification in cGMP.
• Collaborate cross-functionally with analytical and drug product teams.
• Prepare technical documentation and support CMC filings.

Skills

Bioprocess development

Cell culture

Protein purification

GMP knowledge

Data analysis

Regulatory documentation

Education

PhD/PharmD/MD

Master’s + 3 years science

Bachelor’s + 5 years science

Tools

Excel

Spotfire

JMP

Python

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Sr Scientist

What you will do

Let’s do this. Let’s change the world. In this vital role you will design and execute experiments at the bench scale, spanning the end-to-end drug substance process, within cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to technology development. Finally, the candidate will also expand and develop skills within the cell-culture and purification functions, thereby further contributing to the integrated group

• Responsibility 1


• Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation


• Drive innovationandutilizeout-of-the-box thinking to contribute to technology development


• Expand and develop skills in cell culture and purification, thereby further contributing to theintegratedgroup


• Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phaseappropriate manner.


• Deliverprocessamenableto cGMP operation and carry out results of drug substance in a cGMP manufacturing environment


• Author, or provide direction for the authorshipof,technical report or CMC regulatory submissions which may require minimaladditionalediting.

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

OR

Master’s degree and 3 years of Scientific experience

OR

Bachelor’s degree and 5 years of Scientific experience

Preferred Qualifications:

• Ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment.


• Advanced understanding of cell culture and or purification techniques such as aseptic techniques, bioreactor production, harvest operations, protein chromatography, TFF, filtration, etc.; hands‑on experience with cell culture or purification operations needed.


• Extensive experience in development and/or support of biomanufacturing processes, including process scale‑up and GMP production.


• Prior experience with data analytical tools (Excel, Spotfire, etc.) is preferred. Experience with statistical analysis and programming in JMP, R, and/or Python environments is a plus.


• Motivated self‑starter with excellent oral and written communication, interpersonal, and organizational skills.


• Team player with the ability to successfully work within a diverse team in a dynamic, cross‑functional environment.


• Familiarity with design of experiments and statistical analysis of data is desirable.


• Track record of innovation and implementation of new technologies.


• Experience in authoring CMC regulatory documents in support of Amgen’s regulatory filings.

What you can expect from 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, we’ll 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.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.