Sr. Manager Process Development - Drug Product

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It's time for a career you can be proud of.

Senior Manager Process Development - Drug Product

Live

What you will do

Let's do this. Let's change the world! In this vital role you will direct activities of the technical services group to support manufacturing. Lead an organization to ensure that the appropriate quality support is provided. Specific responsibilities include but are not limited to:

• Plan, coordinate and implements manufacturing technical service activities which include new product introductions, process improvements, validations etc.
• Interface with plant managers, i.e., production managers and senior process development staff to assess needs and update progress.
• Provides guidance to subordinates based on departmental/site goals and company policy.
• Work is reviewed in terms of meeting functional objectives and schedules.
• Determines and pursues courses of action necessary to obtain desired functional results.
• Work checked through consultation and agreement with others rather than by formal review of supervisor.
• Accomplishes results through mid-level supervisors to senior exempt specialist employees with direct reports.
• Responsible for all projects assigned to their functional organization.
• Acts as an advisor to subordinate supervisors or staff members to meet schedules.
• Directly participates in establishing and administering many centralized departmental projects.
• Develop goals and objectives for the group and provide group technical guidance.
• Make budget recommendation and oversee expenditures.
• Supervise staff, providing performance appraisals, hiring, and handling staff relations issues
• Develops, executes, and documents all PD activities required to support technology transfer.
• Provides technical support in the resolution of investigations and CAPA's. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept.
• Provides support to regulatory filings & audits and for Validation & Regulatory strategies.
• Ensures that industry standards and best practices that fits Amgen's business needs are effectively applied.
• Participate in technical forums for sharing of best practices and application of biotechnology platforms and scientific expertise.
• Apply advanced technical principles, theories, and concepts in the development of new principles and concepts, related to biotechnology manufacturing.
• Interacts with corporate and site partners to establish and maintain partnership agreements

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Senior Manager Process Development professional we seek is a strong leader with these qualifications.

• Bachelor's degree & 8 years of Process Development, Quality and/or direct Manufacturing support GMP regulated industry experience

OR

• Master's degree & 6 years of Process Development, Quality and/or direct Manufacturing support GMP regulated industry experience

OR

• Doctorate degree & 2 years of Process Development, Quality and/or direct Manufacturing support GMP regulated industry experience

And

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Beyond that, additional preferred qualifications are:

• Educational background in Life Science and/or Engineering
• Experience managing technical groups and advanced scientific analysis and troubleshooting skills
• Solid written and verbal communication skills in English and Spanish.
• Strong organizational skills with the ability to prioritize efforts and delegates resources.
• Multi-task project expertise.
• Experience with equipment commissioning and qualification, validation and documentation processes in a highly regulated environment
• Demonstrated external scientific track record which may include peer reviewed publications, scientific conference participation or participation in industry working groups or panels
• Advanced scientific writing, problem solving skills and abilities with technology commercialization
• Familiarity with documentation in a highly regulated environment and ability to interpret & apply GMPs.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a 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 an accommodation.

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.