Specialist Manufacturing: NPI, Upstream Process Owner-Holly Springs,NC
Specialist Manufacturing: NPI, Upstream Process Owner-Holly Springs,NC
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$ 139179 - 139179
1 Vacancy
Job Description
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 awardwinning 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.
Specialist Manufacturing: NPI Upstream Process Owner
What you will do
Lets do this. Lets 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 ANCs Manufacturing Support team this position is responsible for ensuring new products are successfully introduced into ANCs biologics manufacturing facility and ownership of upstream unit operations. It is a highly visible role across the site with the core responsibility of hosting crossfunctional 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 ontime 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.
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 crossfunctional 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
Associates degree and 8 years of biotechnology operations experience OR
Bachelors degree and 4 years of biotechnology operations experience OR
Masters degree and 2 years of biotechnology operations experience OR
Doctorate degree
Preferred Qualifications:
Degree in Chemical Engineering Industrial Engineering Biology or Biochemistry
Excellent crossfunctional 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
112977.00 USD 139179.00 USD
Required Experience:
Unclear Seniority
Employment Type
Full Time
