Process Development Senior Scientist

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. 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 Senior Scientist

What you will do

Let’s do this! Let’s change the world!

Amgen is seeking a Process Development Scientist within our Pre-pivotal Bioprocess Development (BD) organization based at our Thousand Oaks, California campus. Pre-pivotal BD is responsible for the development, scale-up, and transfer of both upstream and downstream processes for early clinical manufacturing of therapeutic molecules. The programs develop a wide range of biological molecules including mAbs, BiTEs, bispecifics, conjugations, and other novel modalities ranging from early molecule assessments with Research to IND enabling GMP manufacturing supplies for clinical studies.

The primary focus of this position will be downstream purification development. The drug substance development deliverables for this role include molecule assessments, clone selections, First-In-Human (FIH) purification process development, and tech transfers to clinical manufacturing. In addition, the role will entail the development and implementation of new purification technologies, authoring regulatory CMC documents, and evaluating process capabilities for viral clearance.

Key Responsibilities

• Leading a team of purification scientists to develop processes for clinical manufacturing

• Applying technical and platform knowledge to design studies for the development of purification processes

• Serving in cross-functional or cross-site roles

• Contributing to the scientific literature and conferences, gaining recognition as a subject-matter expert in both internal and external purification communities

• Investigating and implementing relevant new technologies

• Interfacing with regulatory agencies in support of CMC filings

• Analyzing and presenting data internally for governance and technical meetings

• Contributing to viral clearance process evaluations and company strategies

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a Scientist with these qualifications.

Basic Qualifications:

• Bachelor’s degree and 5 years of Scientific experience OR

• Master’s degree and 3 years of Scientific experience OR

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

Preferred Qualifications:

• Doctorate in Chemical Engineering, Biochemistry, Biology, or related discipline

• Experience contributing to and/or participating in purification science.

• Expertise and experience in purification process development

• Extensive experience in development and/or support of bio-manufacturing processes, including process scale-up and GMP production

• Track record of innovation and implementation of new technologies

• Experience in authoring IND sections and interaction with regulatory agencies

• Experience in viral clearance evaluation per ICH Q5A guidelines

• Understands purification techniques for biological molecules (e.g. chromatography, depth filtration, viral filtration, tangential flow filtration, centrifugation, etc.)

• Independently authors technical reports, regulatory filings, patents, and peer reviewed publications

• Capable of conveying information and recommendations on scientific issues to senior management

• Serves as a technical authority and keeps current in relevant literature and related technology

• Works cross-functionally to author CMC documents in support of Amgen’s regulatory filings

• Develops processes to deliver multi-kilogram quantities of drug substance to cGMP operation

• Leads deliveries of drug substance in a cGMP manufacturing environment in both internal and external capacity

• Ensures that safe laboratory practices are followed

• Provides mentoring and expertise to less-experienced staff

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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

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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.