Specialist Manufacturing New Product Introduction – Holly Springs, NC
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Job Location:
Holly Springs, MS - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans 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.
Live
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. 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. This role will also offer the opportunity to propose participate and lead team improvement initiatives to drive improved productivity and scheduling accuracy.
New Product Introduction 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).
Technical expert who leads or participates in projects ensuring that production documents are accurate and up to date.
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.
Champions Lean Transformation and OE initiatives facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
Live
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. 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. This role will also offer the opportunity to propose participate and lead team improvement initiatives to drive improved productivity and scheduling accuracy.
New Product Introduction 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).
Technical expert who leads or participates in projects ensuring that production documents are accurate and up to date.
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.
Champions Lean Transformation and OE initiatives facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
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 DS 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 GMP manufacturing operations
Strong technical knowledge of drug substance processing (chromatography filtration buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing (cell culture harvest)
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
Required Experience:
IC
Key Skills
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
