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Manager – New Product Introduction (NPI)


This is a Contract position in Los Angeles, CA posted August 2, 2022.


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.

Manager-New Product Information (NPI) Live What you will do Lets do this.

Lets change the world.

In this vital role you will act as the Manager for the New Product Introduction (NPI) Team in 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 NPI team 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.

Directly manage a team of NPI Specialists responsible for introduction of new products and/or advanced technologies into the plant.

Includes hiring, training, oversight, performance evaluations, and development.

Proactively assess NPI team capabilities to meet the evolving drug substance clinical supply needs (ex.

resources, platform technical understanding, cross-functional alignment).

Lead upstream/downstream area team meetings and drive alignment in business processes across the team.

Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality as well as Manufacturing for the introduction of new products and/or advanced technologies into the plant.

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 ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings.

Drive a culture of inspection readiness across the team by ensuring NPI playbook is kept up to date and supporting staff with audit or regulatory response strategy.

Win 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 a collaborative partner with these qualifications.

Basic Qualifications: Doctorate degree OR Masters degree in chemistry, biology or engineering & 2 years of biotechnology operations experience or Bachelors degree & 4 years of biotechnology operations experience or Associates degree & 10 years of biotechnology operations experience or High school diploma / GED & 12 years of biotechnology operations experience Preferred Qualifications: Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry Experience leading/managing a team of direct reports Experience with PAS X, Werum software Experience in GMP operations, including New Product Introduction (NPI) 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 Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, we also 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 Apply now for a career that defies imagination Objects in your future are closer than they appear.

Join us. 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.

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, Puerto Rico and Canada 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.