Manager Manufacturing, New Product Introduction (NPI)

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Manager Manufacturing New Product Introduction

What you will do

Lets do this. Lets change the this vital role you will act as the Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply. This position is within Amgen North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support organization.

ANC is a dynamic environment and an important supply facility for Amgens pipeline products. The GMP DSS plant manufactures drug substance for clinical trials and commercial supply through GMP 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 leads responsible for introduction of new products and/or advanced technologies into the plant. Includes hiring training oversight performance evaluations and development.
• Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs (ex. resources platform technical understanding cross-functional alignment).
• Lead 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 process changes and improvements 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 change controls are kept up to date and supporting staff with audit or regulatory response strategy.
• Interacts with management in planning developing and maintaining budget
• Assist in developing and maintaining department goals
• Interact with regulatory agencies as needed
• Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement
• Responsible for selection training evaluation staff relations and staff development
• Mentor and coach staff members to live by the Amgen Values
• Develop and implement trainings plans and programs to ensure staff are prepared and compliant
• Other functional responsibilities may be assigned

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a type of person with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Manufacturing or Operations experience OR
• Associates degree and 10 years of Manufacturing or Operations experience OR
• Bachelors degree and 5 years of Manufacturing or Operations experience OR
• Masters degree and 3 years of Manufacturing or Operations experience OR
• Doctorate degree

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

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

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.

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