Career Category Process Development Job Description The role After completion of the onboarding and applicable training qualifications; you will join a team focused on Purification Sciences and Engineering to support Drug Substance manufacturing operations and subsequently impact patients lives every day. Day to day activities will include oversight of laboratory bench scale execution and on-the-floor commercial support to the manufacturing facilities. This is an exceptional opportunity to gain a deep insight into development and optimization of processes as well as processes technology transfer activities across different Amgen sites. The talented professional will function as a manager, lead scientific / technical resource and/or as a project leader for complex projects with high visibility. The Senior Manager Process Development will lead a group of Purification Scientists and Engineers who provide product and process technical support to commercial operations. As part of this leadership role, he/she will develop strong teams and support staff in career development. The scope of work and responsibility span commercial process development, support of technology transfer, authoring regulatory CMC documents, and interacting with regulatory agencies. In addition, the position will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency. The department The Purification Sciences and Engineering team provides cross-functional support to AMLs drug substance manufacturing operations. With a state-of-the-art laboratory facility, this team also collaborates and closely works with Amgens manufacturing network to ensure innovation is incorporated into our processes and ensure product delivery. We are a highly dedicated team that utilizes our strength in protein sciences and purification downstream operations in support of our role serving patients. SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO : Develop goals and objectives for the group Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations Make budget recommendation and oversee expenditures. Supervise staff, providing performance appraisals, hiring, and handling staff relations issues. Identifies relevant external competitive knowledge Independently prepares new and novel protocols/experimental design Initiates productive collaborations outside of the department or company Introduces new or advanced technologies and/or concepts May contribute to scientific journal articles or complex technical documents as lead author Leads department-wide support efforts such as safety, recruiting and committees Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources. Basic Qualifications / Education & Experience Doctorate degree and 2 years of experience in GMP environment OR Master degree and 6 years of experience in GMP environment OR Bachelor degree and 8 years of experience in GMP environment AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources. Beyond that, additional preferred qualifications are: - Educational background in Life Sciences and/or Engineering - Master or Doctorate degree - Purification experience in a biopharmaceutical manufacturing industry - Extensive experience in development and/or support of commercial manufacturing processes at scale, including process scale-up - Extensive experience conducting and/or overseeing purification laboratory activities at bench scale - Experience resolving technical issues and knowledge of requirements to produce therapeutic proteins derived from mammalian and bacterial cell culture is essential - Ability to motivate, lead and/or supervise the activities of others. - Demonstrate skills in independently determining and developing scientific analysis and solutions. - Track record of innovation and implementation of new technologies - Demonstrate strong laboratory and project management skills. - Experience in process validation/process performance qualification - Experience in authoring BLA sections and interaction with regulatory agencies The benefits Our broad approach is one of the reasons why we are regularly recognized as a Best Place To Work. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program and on-site child care and fitness facilities you will find us focused on your well-being too. 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. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. 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 uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If 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. .
