As part of Amgens Process Development organization, Drug Product Technologies (DPT) is seeking a highly motivated 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 and continuous process verification. This position is based in Thousand Oaks, CA at the Amgen headquarters.
- New Product Introductions
- Interfaces with all cross functional areas of the Amgen Thousand Oaks (ATO) DP manufacturing plant to ensure the aseptic fill finish equipment and procedures that constitute the DP platform processes are fully characterized to enable efficient and successful tech transfers of Amgens clinical & commercial product portfolio.
- Supports new product introductions and lifecycle changes into the ATO DP manufacturing site by integrating the products process design and requirements with the sites procedures and capabilities.
- Designs, executes and documents off-line and on-site DP characterization studies.
- Designs, plans and provides floor support to on-site engineering, machinability, and process performance qualifications (PPQ) runs
- Supports make-a-batch exercises to determine facility fit and identify gaps.
- Author and/or own high-quality process technology transfer and other technical documents.
- Development of validation plans, PPQ protocols and reports for commercial manufacturing in alignment with GMP quality system documentation standards.
- Manufacturing Support
- Lead or assist in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Troubleshoots issues with drug product processing technologies and equipment.
- Conducts risk assessment for drug product operations and propose / implement appropriate CAPA for continuous improvement
- Interfaces with manufacturing as well as all support functions such as engineering, quality, and drug product technologies to provide robust and coordinated support to manufacturing.
- Identifies and implements new process improvements for current and new sterile operations for increased reliability, agility and efficiency in plant operations
- Aseptic DP Technology leadership
- Serve as SME in introducing new DP manufacturing technologies in the ATO site and work with global cross-functional teams for shared best practices in technical advancements across Amgen clinical and commercial fill-finish plants.
- Work individually and with a team of engineers to design, execute and document primary data packages related to new technology development, while demonstrating specific expertise in aseptic processing and unit operations characterization
- Supports expansion projects by supporting equipment user requirements, FAT, Process Characterization and Validation in all sterile fill finish processing areas.
- Support the use of single-use systems and platforms in drug product manufacturing process
- Masters degree OR
- Bachelor's Degree and 2 years of relevant experience
- Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology or related technical field of study in biotechnology, life sciences or related discipline.
- 2+ years of experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites
- Experience in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
- Ability to work on multiple projects simultaneously, learn new techniques, keep accurate records, follow SOPs and instructions in compliance with company policies, and comfortable to operate in a very flexible, agile environment
- Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports
- Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with some oversight
- Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
- Demonstrated ability to use interpersonal skills to build strong technical relationships.
- Self-motivation, adaptability and a positive attitude.
- Excellent communication skills, both oral and written.
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.