Specialist Manufacturing: NPI, Upstream Process Owner-Holly Springs,NC Position Available In Wake, North Carolina

• 444736BR
• Auto req

ID:

• 444736BR

• Company:

• Amgen

• Job Code:

• Pharmaceutical Pharmaceutical

• Job Description:

• _

ATTENTION MILITARY AFFILIATED JOB SEEKERS

_

• – Our organization works with partner companies to source qualified talent for their open roles.

The following position is available to _Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers_ . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is “On-Site” at the location detailed in the job post. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Specialist Manufacturing:

NPI, Upstream Process Owner What you will do Let’s do this. Let’s change the world. In 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 ANC’s Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of upstream 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 upstream 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). Upstream 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.

• Position Title:

• Specialist Manufacturing:

  NPI, Upstream Process Owner-Holly Springs,NC

• Job Category:

• Manufacturing

• Minimum Education Required:

• High School/GED
• City
• :•Holly Springs •

Additional Qualifications/Responsibilities:

• 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 Upstream manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications:

High school diploma / GED and 10 years of biotechnology operations experience OR Associate’s degree and 8 years of biotechnology operations experience OR Bachelor’s degree and 4 years of biotechnology operations experience OR Master’s degree and 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 Upstream GMP manufacturing operations Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) 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 Salary Range 112,977.00 USD – 139,179.00 USD

• State
• :•North Carolina •

Salary Range:

• >$100,000