Process Development Senior Principal Scientist

Amgen•Thousand Oaks, CA

About The Position

Amgen’s Process Development organization, within the Drug Product Technologies unit, develops robust drug product manufacturing processes, CMC sections, and supports the supply of commercial products. The Senior Principal Scientist will lead commercial drug product programs as a Drug Product Team Leader (DPTL), serving as the point of accountability for technical activities related to formulation, aseptic process design and validation, combination products, process improvements, lifecycle changes, regulatory submissions, and annual product reviews. The role leads a scientific team responsible for late-stage drug product process development and technology transfer, while supporting clinical and commercial fill/finish operations. It also advances drug product development through process engineering, technological innovation, data analysis, and cross-functional collaboration. The position requires domestic and international travel up to 10% of the time.

Requirements

Doctorate degree (PhD, PharmD, or MD, and relevant postdoctoral experience where applicable) plus 3 years of engineering or science experience; or a master’s degree plus 6 years of engineering or science experience; or a bachelor’s degree plus 8 years of engineering or science experience.
Ability to travel domestically and internationally up to 10% of the time.

Nice To Haves

Advanced degree in Pharmaceutics, Biotechnology, Engineering, or a related discipline, and industry experience in pharmaceuticals or biotechnology.
Demonstrated knowledge of drug product commercialization and integrated combination product development, with hands-on end-to-end development experience for liquid, lyophilized, and/or oral solid dosage drug products in various presentations.
Experience in process transfers, control strategy, authoring marketing applications, developing robust responses to regulatory questions, supporting validation activities, and supporting pre-approval inspections at commercial sites.
Understanding of protein physical and chemical stability and how process-related stress affects product quality, particularly the impact of freezing and drying on short- and long-term stability.
Strong knowledge of process development using single-use manufacturing equipment.
Aseptic processing experience and familiarity with cGMPs and ICH guidelines.
Experience with new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control, and statistical design and analysis of experiments.
Strong problem-solving and cross-functional communication skills.
Proven ability to learn and act on dynamic information rapidly.
Ability to participate in global cross-functional teams and work effectively in a highly matrixed environment to lead change, improve efficiency, and build strong cross-functional relationships.

Responsibilities

Lead commercial drug product programs as a Drug Product Team Leader and lead a scientific team supporting the commercial drug product portfolio.
Plan, design, execute, and document laboratory studies related to drug product design, formulation, and process development for commercialization and lifecycle management of parenteral presentations.
Lead late-stage drug product process development and technology transfer, and coach staff with an emphasis on people-centered leadership.
Support clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes or improvements.
Drive continuous improvement in drug product development through technological innovation and application of first principles in process engineering.
Participate in and lead global cross-functional teams to influence and drive change and efficiency and foster strong relationships.
Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions, and develop responses to regulatory questions.
Deliver progress reports and presentations to keep management aware of program and functional status, progress, and future needs.
Use advanced information systems to improve drug product design through faster data availability, historical information, large-data-set analysis, and statistical analysis.