What are the responsibilities and job description for the Specialist Manufacturing NPI Process Owner - Holly Springs NC position at VetJobs?
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.
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 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.
Auto req ID
441189BR
Minimum Education Required
High School/GED
Job_Category
Maintenance
Additional Qualifications/Responsibilities
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 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, we’ll 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
Salary Range
112,977.00 USD - 139,179.00 USD
City*
Holly Springs
State*
North Carolina
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
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.
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 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.
Auto req ID
441189BR
Minimum Education Required
High School/GED
Job_Category
Maintenance
Additional Qualifications/Responsibilities
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 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, we’ll 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
Salary Range
112,977.00 USD - 139,179.00 USD
City*
Holly Springs
State*
North Carolina
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
