Process Development Senior Scientist Full-time

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

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

We 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.

• Doctorate degree
• 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

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.

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