Career CategoryScientific
Job DescriptionProcess Development Senior ScientistWhat you will doLet's do this. Let's change the world. In 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 Amgen's rich, exciting and dynamic pipeline. With Amgen's 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 siRNAs.
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 utilize 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 youWe are all different, yet we all use our outstanding contributions to serve patients. The collaborative professional we seek is a dynamic thought leader with these qualifications.
Basic Qualifications: OR
- Master's degree and 4 years of life sciences experience
OR
- Bachelor's degree and 6 years of life sciences experience
OR
- Associate's degree and 10 years of Engineering experience
OR
- High School diploma / GED and 12 years of Engineering experience
Preferred Qualifications:- Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing discipline or relevant experience in the pharmaceutical or related industry
- Experience in bioreactor process development or cell line development
- Scientific understanding of current bioreactor technologies, as well as the ability to explore and develop new approaches to further advance innovative bioreactor technologies
- Understanding of protein characteristics and critical attributes so as to direct bioreactor development and product/process control strategies
- Independently uncovering and resolving issues associated with cell culture and harvest and implementation of scientific projects
- Strong technical communication skills, both written and verbal, to interact effectively and appropriately with all stakeholders and document learned information, improvements, and value generated
- Motivated self-starter with excellent interpersonal and organizational skills
- Leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a group of scientists to deliver on complex and challenging objectives in defined timelines
- 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 application and the drug development process
- Exposure to cGMP manufacturing and CMC components of regulatory submissions
What you can expect of usAs 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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 deadlineAmgen 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.
SponsorshipSponsorship for this role is not guaranteed.
