Process Development Senior Scientist

Let’s do this. Let’s change the world. In this vital role you will be responsible fordevelopment, characterization, scale-up and support of drug substance processes to enable commercial advancement of programs from Ph II/III clinical trials to marketingapplication.

Work in a coordinated group in which cell culture and purification scientists work together to advance Amgen’s rich,excitingand dynamic pipeline. With Amgen’s biology first approach, the positionprovidesthe outstanding opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses tobispecificsand siRNAs.

The Pivotal Drug Substance Process Development organization at Amgen develops,characterizesand supports the commercialization ofbiologicsdrug 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 innovationandutilizeout-of-the-box thinking to contribute to technology development
• Expand and develop skills in purification and cell culture, 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

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
OR
Master’s degree and 2 years of Life Sciences experience
OR
Bachelor’s degree and 4 years of Life Sciences experience

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
• Demonstrated 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

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.

careers.amgen.com

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.

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 for this role is not guaranteed.

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Salary Range