Process Development Senior Scientist

About the role

Join Amgen’s mission of serving patients. In this vital role, you will be responsible for the development, characterization, scale-up, and support of drug substance processes to enable commercial advancement of programs from Phase II/III clinical trials to marketing application. Work in a coordinated group where cell culture and purification scientists collaborate to advance Amgen’s rich, exciting, and dynamic pipeline.

With Amgen’s biology-first approach, this position offers the opportunity to work on multiple modalities, including antibodies, oncolytic viruses, bispecifics, and siRNAs. The Pivotal Drug Substance Process Development organization develops, characterizes, and supports the commercialization of biologics drug substance manufacturing processes for all late-stage programs across the Amgen portfolio.

Responsibilities

• 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, 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 processes 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 reports or CMC regulatory submissions which may require minimal additional editing.

Requirements

• 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

• 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 advance innovative bioreactor technologies.
• Understanding of protein characteristics and critical attributes to direct bioreactor development and product/process control strategies.
• Ability to independently uncover and resolve issues associated with cell culture and harvest and implement scientific projects.
• Strong technical communication skills, both written and verbal, to interact effectively 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 within 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.

Benefits

Amgen offers 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.

Pay

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.