MANUFACTURING SPECIALIST - MES LEAD
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.
What you will do
Lets do this. Lets change the world. In this vital role you will act as the Manufacturing Execution Systems (MES) Lead for GMP Drug Product Fill Finish Facility.
The ATO Fill Finish facility is a dynamic environment and an important launch point for Amgens pipeline products. The GMP Drug Product Fill Finish Facility manufactures drug product for clinical trials through commercial production using single-use equipment platforms and stainless steel. This role is a key communication and technical interface function and the Specialist Manufacturing - MES Lead will act as a liaison between the GMP manufacturing operations teams and NPI, Supply Chain, Facilities & Engineering, and Process Development.
Job scope and responsibilities:
- Manufacturing Execution Systems (MES) Lead will be responsible for the design, authoring, implementation and validation of the Electronic Batch Records used in the plants.
- Directly manage a small team of MES editors.
- Lead the troubleshooting, problem solving and RCAs associated with MES. Develop and own countermeasures to prevent error recurrence.
- Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement and data digitization in the plant. Leads integration with data management tools.
- Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings associated with MES in the plant.
- Technical expert who leads or participates in projects to introduce new digital technologies into the plant.
- Represents the plant on global MES network and initiatives.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The biotech/pharma professional we seek is a collaborative team-player with these qualifications.
Doctorate degree OR
Masters degree in chemistry, biology, computer science or engineering and 3 years of MES biotechnology operations experience OR
Bachelors degree and 5 years of MES biotechnology operations experience OR
Associates degree and 10 years of MES biotechnology operations experience OR
High school diploma / GED and 12 years of MES biotechnology operations experience
- Extensive experience with electronic documentation systems in a regulated environment
- Experience with PAS X, Werum software with capability to create and edit in EBR
- Experience in GMP operations
- Technical knowledge of drug product operations
- Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
- Ability to coach, mentor and/or cross train colleagues within core technical areas
- Background in lean manufacturing methodologies and operational excellence
- Experience in cross functional Project Management
- Experience validating computer based systems
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.
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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.
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.