As part of Amgens Process Development organization, Drug Product Technologies (DPT) is seeking a highly motivated Principal Engineer to provide process development support to Amgens clinical and commercial sterile fill-finish manufacturing plant in Thousand Oaks, CA. The candidate will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation, continuous process verification and general manufacturing support.
Key responsibilities for this role are:
- Accountable for successfully executing all site process development activities to enable clinical and commercial tech transfers of parenteral drug products to Amgens drug product manufacturing facility in Thousand Oaks
- Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support clinical and commercial drug product manufacturing operations with technical evaluation of deviations.
- Accountable for process validation of commercial products in adherence to applicable regulations (FDA, EU & global standards) and required policies and procedures, including safety and training
- Interface with manufacturing and other plant support functions (QA, engineering, regulatory) to implement process improvements
- Manage and supervise a team of tech transfer leads responsible to assess facility-to-process fit during make-a-batch exercise, ensure transferability of off-line characterization studies, design and execute on-site characterization studies and process validation runs, author/own high quality technical documents and regulatory files, provide on-site support and evaluate product impact due to process, scale, equipment and raw material changes.
- Accountable for building, owning and maturing business processes to manage NPI/tech transfer portfolio for all drug product commercial tech transfers to the Thousand Oaks manufacturing facility in a tactical, strategic and agile manner, ensuring successful project completion, and driving continuous improvement, increasing team productivity and efficient use of available resources, as demonstrated by performance metrics
- Build, maintain and improve tech transfer efficiency tools, including utilization of offline characterization capabilities and predictive models, development of templated documents, implementation of lessons learned and more.
- Build and own site assessment business process for new product introductions and represent the plant in engagement with the network and operations strategy planning teams
- Build and sustain excellent relationships with partners drug product teams, NPI, QA, Supply Chain, Process Development and manufacturing teams to ensure alignment between program needs and site capabilities
- Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as required, and support PAI, GMP inspections in the plant
- Participates in site selection to provide technical fit of new product process requirements to manufacturing capabilities and a realistic account of resources for tech transfer and manufacturing support post approval
- Deliver progress reports and presentations, including generation and upkeep of dashboards to ensure management is aware of status and progress. Escalate issues, recommendations on unresolved challenges in a professional and timely manner to the appropriate governance.
- Doctorate degree&2years ofEngineeringor Process Development experienceOR
- Masters degree &6years ofOperations or Process Development experienceOR
- Bachelors degree &8years ofOperations or Process Developmentexperience
- Advanced degree in engineering, biotechnology, life sciences or related discipline
- 5+ years of experience in the pharmaceutical or biotechnology industry in support of commercial drug product manufacturing that includes areas such as process development, process characterization, technical transfers and validation
- Strong skills in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
- Strong knowledge of Quality systems, drug product manufacturing (GMP) and Validation
- Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
- Demonstrated ability in leading multi-functional teams to advance complex projects to completion and influencing decisions.
- Ability to lead innovation, collaborate in a cross-functional team environment, and act on dynamic information at a rapid pace
- Capable of organizing and communicating complex technical concepts to enable business decisions
- Demonstrated ability to use interpersonal skills to build strong technical relationships.
- Excellent communication skills, both oral and written.
- Ability to elevate relevant issues to project lead and line-management
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.