Process Development Associate Scientist

Career Category Scientific Job Description Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Associate Scientist What you will do Lets do this! Lets change the world! As part of Amgens Process Development organization, Drug Product Technologies (DPT) is seeking a highly dynamic Process Development Associate Scientist with expertise in syringe/vial filling operations to support Amgens clinical and commercial sterile fill-finish manufacturing site in Thousand Oaks, CA. You will play a key role in ensuring robust aseptic processing, seamless technology transfer, process characterization, validation, and continuous verificationhelping bring high-quality medicines to patients worldwide. Key Responsibilities: Manufacturing Support Lead and implement characterization studies on the floor including fill recipe development for syringes and vials, process characterization, tech transfer studies, process validation, and ongoing commercial manufacturing. Lead or assist in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Address issues with drug product processing technologies and equipment. Conducts risk assessment for drug product operations and propose / implement appropriate CAPA for continuous improvement. Collaborate 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. Work with multi-functional teams conducting FMEAs, risk assessments, author technical protocols, reports and CMC subsections and present findings and project status. Aseptic DP Technology leadership Serve as SME in introducing new DP manufacturing technologies in the ATO site and work with global multi-functional teams for shared standard processes in technical advancements across Amgen clinical and commercial fill-finish plants. Drive innovations in aseptic processes, technologies and techniques, all in alignment with evolving regulatory expectations and internal quality standards, leading to continuous improvement in GMP drug product manufacturing. Work individually and with a team of engineers to design, implement 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. DP Network support Establishes strong working relationships with partner sites across DP Manufacturing network to champion the sharing of technical standards, improvement opportunities and lessons learned to deliver high-quality manufacturing processes. Acts as Point of Contact (POC) to drug product teams to guide/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization and inspection. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. Basic Qualifications: Masters degree and 1 year of Scientific, Engineering and/or Operations experience OR Bachelors degree and 3 years of Scientific, Engineering and/or Operations experience Preferred Qualifications: Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology or related technical field of study in biotechnology, life sciences or related field. 3+ 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. Project management skills, including the ability to handle numerous projects and evaluate project resource requirements. Demonstrated ability in providing leadership to multi-functional teams to advance complex projects to completion and influencing decisions. Ability to lead innovation, collaborate in a multi-functional team environment, and act on dynamic information at a rapid pace Ability to independently design and implement 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 limited oversight Capable of organizing and communicating complex technical concepts to enable business decisions Solid understanding of Quality systems and Drug Product Manufacturing (GMP).s Demonstrated ability to use interpersonal skills to build strong technical relationships. Self-motivation, adaptability and a positive demeanor. Excellent communication skills, both oral and written. Ability to elevate relevant issues to project lead and line-management. Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: 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, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 96,605.00 USD - 119,055.00 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen