New Product Introduction (NPI) Team Lead - Specialist
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
New Product Introduction (NPI) Team Lead - SpecialistLive
What you will do
Lets do this. Lets change the world. In this vital role you will act as the New Product Introduction (NPI) Team Lead for B23 GMP Drug Substance Supply. This position is within Amgen Thousand Oaks (ATO) Manufacturing and Clinical Supply - Manufacturing Systems organization.
ATO B23 is a dynamic environment and an important launch point for Amgens pipeline products. The GMP DSS plant manufactures drug substance for clinical trials through commercial production using both stainless steel and single-use equipment platforms. This role is a key communication and technical interface between the GMP manufacturing operations teams in the plant and Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality.
- New Product Introduction lead coordinating with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality as well as Manufacturing to introduce new products and/or advanced technologies into the plant.
- Directly manage a small team of NPI Specialists.
- Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date.
- Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
- Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
- Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings.
- Generate electronic and paper process documents to assure plant success. Provide input to electronic batch record editing and troubleshooting to support production, as required.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an individual with these qualifications.Basic Qualifications:
Doctorate degree OR
Masters degree in chemistry, biology or engineering & 3 years of biotechnology operations experience or
Bachelors degree & 5 years of biotechnology operations experience or
Associates degree & 10 years of biotechnology operations experience or
High school diploma / GED & 12 years of biotechnology operations experiencePreferred Qualifications:
- Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry
- Excellent technical writing skills and experience with electronic documentation systems
- Experience with PAS X, Werum software
- Experience in GMP operations
- Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
- Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
- 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
Some of the vast rewards of working here
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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.
We will ensure that individuals with disabilities are provided 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 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.