Senior Manager Manufacturing
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Senior Manager ManufacturingLive
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for oversight of several areas of the GMP plant for Drug Product at the Thousand Oaks campus.
- Responsible for management and oversight of a diverse team of technical staff with areas of deep expertise, while building flexibility and agility into the group
- Accountable for NPIs, change control ownership, procedural updates, validation, and project support for DP clinical manufacturing
- Responsible for qualification of multi-million dollar on-going and new capital projects
- Continuous improvement through optimization validation strategies of media fill and cleaning programs for DP manufacturing
- Lead a team of process owners, supporting every area of DP manufacturing process
- Provide strategic oversight for implementation/validation of single use (disposable) technologies across multiple unit operations and filling technologies
- Support on-site audits from regulatory agencies, partners or internal investigators
- Ensure equipment, process and procedures are compliant with cGMP requirements and/or other applicable regulations
- Ensure written procedures or protocols describing manufacturing or qualification operations are accurate, approved and implemented
- Collaborate with cross-functional teams in completing production activities
- Lead or support continual improvement initiatives, programs and projects
- Represent DP Technical Transfer operations in cross network/site initiatives
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Manufacturing professional we seek is a collaborative partner with these qualifications.Basic Qualifications:
- Doctorate degree and 2 years of Manufacturing and Operations experience OR
- Masters degree and 6 years of Manufacturing and Operations experience OR
- Bachelors degree and 8 years of Manufacturing and Operations experience OR
- Associates degree and 10 years of Manufacturing and Operations experience OR
- High school diploma / GED and 12 years of Manufacturing and Operations experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Bachelors Degree in Life Sciences, Physical Sciences, Engineering or Process Manufacturing
- 8+ years of related lab, manufacturing or healthcare operational experience.
- 6+ years of leadership experience with 2 or more years as a cross-functional team leader including experience in performance management, technical problem solving, and managing projects (or equivalent/lateral experience).
- 4+ years experience with a compliant highly regulated organization, cGMP or other, including advancing compliant operations.
- Technical writing experience
- Staff and team development.
- Able to recommend, judge, and make good decisions in complex situations.
- Able to positively advance the culture of an organization.
- Managing and coaching conflict effectively.
- Overall understanding of mechanical, technical and operational systems.
- Budgeting, goal setting, capacity planning, inventory control, lean principles, value stream mapping.
- In depth business understanding of manufacturing or operations in biotechnology / biopharmaceuticals / pharmaceuticals industry.
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
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.
#Operations21Equal 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 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.