Specialist Manufacturing NPI, Process Owner

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.

Specialist Manufacturing: NPI Process Owner

What you will do

Lets do this. Lets change the this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANCs Manufacturing Support team this position is responsible for ensuring new products are successfully introduced into ANCs biologics manufacturing facility and ownership of downstream unit operations. It is a highly visible role across the site with the core responsibility of hosting cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations.

• New Product Introduction (NPI) lead coordinating with Manufacturing Process Development Supply Chain Planning Facilities and Engineering as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet).

• Downstream biologics drug substance technical expert who leads or participates in projects including aiding in commissioning and qualification and training staff on equipment and processes

• Support Manufacturing in troubleshooting problem solving and RCAs. Support CAPA development to prevent error recurrence.

• Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion. Responds to regulatory questions and/or audit findings.

• Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics Drug Substance Downstream manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications:

• High school diploma / GED & 10 years of biotechnology operations experience OR

• Associates degree & 8 years of biotechnology operations experience OR

• Bachelors degree and 4 years of biotechnology operations experience OR

• Masters degree in chemistry biology or engineering & 2 years of biotechnology operations experience OR

• Doctorate degree

Preferred Qualifications:

• Degree in Chemical Engineering Industrial Engineering Biology or Biochemistry

• Excellent cross-functional project management meeting facilitation and technical writing skills

• Experience in Downstream GMP manufacturing operations

• Strong technical knowledge of drug substance processing (harvest chromatography filtration buffer preparation) 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

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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