Process Development Senior Scientist - Downstream Purification

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.

Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements.

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

In this vital role you will focus primarily on downstream purification development. The drug substance development deliverables for this role include molecule assessments, 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.

• Leading within 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 an individual 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

Preferred Qualifications :

• Doctorate in Chemical Engineering, Biochemistry, Biology, or related discipline or Master’s degree with 7 years of 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

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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.

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