Process Development Senior Associate Scientist

Amgen is seeking a Process Development Senior Associate Scientist to join the Pivotal Drug Substance Technologies organization in Thousand Oaks, CA. The pivotal DST organization is responsible for developing cell culture and purification manufacturing processes for Amgen's late stage pipeline.

Scope of work includes developing purification processes for recombinant proteins to maximize the recovery and purification yields, evaluating process robustness through process characterization, transferring processes to manufacturing, and conducting other relevant experiments such as for facility fit and raw material evaluation.

Responsibilities:

• Design and execute purification experiments, mainly chromatography and filtration, at bench and pilot scales with high degree of independence
• Document experimental data in lab notebooks. Analyze and interpret data with strong scientific understanding
• Present data to the team and design follow-up experiments as needed
• Author technical reports and regulatory filing documents
• Transfer processes from process development to manufacturing and provide on-the-floor technical support and assist in trouble shooting as needed
• Serve as a subject matter expert in downstream processing. Coach and provide technical guidance to junior team members
• Work with colleagues from the same function and cross functionally from analytical sciences, drug product, and manufacturing teams to meet deliverables for the project
• Contribute to technology development projects to seek continuous improvement in reliability and efficiency

The Associate will have opportunities to cross train in cell culture development and become a well-rounded process development scientist with experience in upstream and downstream.

Basic Qualifications:

Master's degree and 3 years of scientific experience

OR

Bachelor's degree and 5 years of scientific experience

Preferred Qualifications:

• Degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing discipline or relevant experience in the pharmaceutical or related industry preferred
• 4+ years of biotech/pharma industry experience with emphasis on recombinant protein purification
• Extensive hands-on experience in chromatography (affinity, ion exchange, mixed mode, etc.) and filtration (depth filtration, tangential flow filtration) unit operations, and strong scientific understanding of these unit operations
• Experience in purification development for biologics, process characterization, and regulatory filing
• Experience in Design of Experiments and statistical analysis
• Strong oral and written communication skills
• Self-motivated. Strong organization and leadership skills
• Strong interpersonal skills, and the ability to work in a dynamic and collaborative environment

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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, or disability status.