Process Development Senior Scientist Pivotal Biologics Drug Substance Technology

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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. 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 - Pivotal Biologics Drug Substance Technology

What you will do

Lets do this. Lets change the this vital role you will be responsible for development characterization scale-up and support of drug substance processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application.

Work in a coordinated group in which cell culture and purification scientists work together to advance Amgens rich exciting and dynamic pipeline. With Amgens biology first approach the position provides the outstanding opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and antibody-drug conjugates.

The Pivotal Drug Substance Process Development organization at Amgen develops characterizes and supports the commercialization of biologics drug substance manufacturing processes for all late-stage programs across the Amgen portfolio.

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

• Drive innovation and apply out-of-the-box thinking to contribute to technology development

• Expand and develop skills in cell culture and purification thereby further contributing to the integrated group

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

• Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment

• Author or provide direction for the authorship of technical report or CMC regulatory submissions which may require minimal additional editing

What we expect of you

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

Basic Qualifications:

• Doctorate degree (Complete degree by 12/2025) OR

• Masters degree and 3 years of life sciences experience OR

• Bachelors degree and 5 years of life sciences experience OR

Preferred Qualifications:

• Doctorate in Chemical Engineering Biochemical Engineering or other relevant sciences

• Consistent track record of decision-making and trouble-shooting protein drug substance purification processes preferably in a process development environment

• Strong understanding and extensive hands-on experience in protein chromatography including affinity ion exchange and hydrophobic interaction chromatography

• Experience in filtration operations including ultrafiltration/diafiltration

• Understanding of protein characteristics and critical attributes to direct product/process control strategies

• Proven ability to independently identify develop and implement scientific solutions to practical problems.

• Motivated self-starter with excellent interpersonal and organizational skills

• Leadership experience of progressively increased scope and ability to encourage and lead a group of scientists

• Eminence in the scientific community through a sustained record of peer reviewed publications

• Demonstrated success working with diverse team members in a dynamic cross-functional environment

• Familiarity with design of experiments and statistical analysis of data

• Knowledge of license applications and the drug development process

• Exposure to cGMP manufacturing and CMC components of regulatory submissions

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 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.

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

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. 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.

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