Senior Manager Process Development - Drug Substance

The role

After completion of the on-boarding and applicable training/qualifications; you will join a team focused on Cell Culture & Engineering processes to support Drug Substance manufacturing operations and subsequently impact patient's lives every day. Day to day activities will include 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 Sr Mgr Process Development will lead a group of cell culture engineers who provide product and process technical support to commercial operations. The manager may also lead a group of cell culture scientist who optimize commercial processes as part of the life cycle management of Amgen's commercial portfolio. 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 Cell Culture, Science and Engineering (CS&E) team provides cross-functional support to AML's drug substance manufacturing operations. With a state of the art laboratory facility, this team also collaborates and closely work with Amgen's 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 cell sciences and upstream 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.

EDUCATION/LICENSES

Basic 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 biochemistry, cell biology and/or chemical engineering
• Experience in mammalian cell culture sciences in bio-pharmaceutical manufacturing.
• Extensive experience in development and/or support of commercial manufacturing processes, including process scale-up
• Experience resolving technical issues and knowledge of requirements to produce therapeutic proteins through mammalian 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 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.

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.