Nitto Denko
About this opportunity
In this role, you will serve as a liaison between the Manufacturing (MFG) team, Process Technology (PT), and Project Management (PM) teams to assure all manufacturing related activities and expectations are communicated to the direct manufacturing team. You will also act as the manufacturing representative on cross functional projects teams and coordinate, manage and communicate the relevant information required to successfully execute a manufacturing campaign.
Key Responsibilities
Attend internal and external project meetings communicating and delivering project team assignments.
Originate, revise, approve, and/or review CGMP documentation including but not limited to:
Process Instructions
Standard Operating Procedures
Change Controls
Planned deviations
Manage customer in the review and revision of CGMP documentation
Create MFG / PT specific document trackers and manage / maintain due dates and communicate delays and risk
Complete project readiness tasks in SAP system (including entry or review of BOMs and Recipes)
Review project specific documents including but not limited to:
Manufacturing Process Outline (MPO)
Manufacturing Process Formula (MPF)
Project Change Controls
Work Orders
Communicate project details and status to Manufacturing and Process Technology Management Staff. Train manufacturing staff on project specific details
Support project specific CAPA investigations and review relevant CAPA reports
Create project specific deliverable schedules based on Master schedule. Manage schedule changes with MFG and the project team and communicate with PM for management.
Provide MFG updates to the project team and / or customers
Participate in project risk assessments with PM and communicate / help manage risk to the manufacturing team.
Assist in technical and safety risk assessment with PT and communicate / help manage risks to the manufacturing team.
Keep detailed records of project campaigns including Project Post-Event Review details
Interact with various functional groups and the customer to accomplish project goals (including but not limited to PD, MFG, AD, ENG, VAL, PM, BD, QA, QC)
for performing all work within company and cGMP regulatory compliance.
Responsible for staying current with the prescribed training curriculum specified for the job title.
Responsible for the implementation of assigned procedures working within defined schedules.
Required Skills/Abilities
Minimum education requirements include a science related Bachelor’s degree with at least 2 years of manufacturing expertise in a CGMP environment or equivalent work experience.
This is specialist position requiring a comprehensive knowledge of the cGMP requirements for pharmaceutical manufacturing or API manufacturing
Strong communication skills and independence are required
Knowledge of biotechnology / chemical manufacturing processes and equipment is required
Knowledge of oligonucleotide chemistry is preferred
The annualized salary range for this position is $62,000.00 - $75,000.00.
#J-18808-Ljbffr
Key Responsibilities
Attend internal and external project meetings communicating and delivering project team assignments.
Originate, revise, approve, and/or review CGMP documentation including but not limited to:
Process Instructions
Standard Operating Procedures
Change Controls
Planned deviations
Manage customer in the review and revision of CGMP documentation
Create MFG / PT specific document trackers and manage / maintain due dates and communicate delays and risk
Complete project readiness tasks in SAP system (including entry or review of BOMs and Recipes)
Review project specific documents including but not limited to:
Manufacturing Process Outline (MPO)
Manufacturing Process Formula (MPF)
Project Change Controls
Work Orders
Communicate project details and status to Manufacturing and Process Technology Management Staff. Train manufacturing staff on project specific details
Support project specific CAPA investigations and review relevant CAPA reports
Create project specific deliverable schedules based on Master schedule. Manage schedule changes with MFG and the project team and communicate with PM for management.
Provide MFG updates to the project team and / or customers
Participate in project risk assessments with PM and communicate / help manage risk to the manufacturing team.
Assist in technical and safety risk assessment with PT and communicate / help manage risks to the manufacturing team.
Keep detailed records of project campaigns including Project Post-Event Review details
Interact with various functional groups and the customer to accomplish project goals (including but not limited to PD, MFG, AD, ENG, VAL, PM, BD, QA, QC)
for performing all work within company and cGMP regulatory compliance.
Responsible for staying current with the prescribed training curriculum specified for the job title.
Responsible for the implementation of assigned procedures working within defined schedules.
Required Skills/Abilities
Minimum education requirements include a science related Bachelor’s degree with at least 2 years of manufacturing expertise in a CGMP environment or equivalent work experience.
This is specialist position requiring a comprehensive knowledge of the cGMP requirements for pharmaceutical manufacturing or API manufacturing
Strong communication skills and independence are required
Knowledge of biotechnology / chemical manufacturing processes and equipment is required
Knowledge of oligonucleotide chemistry is preferred
The annualized salary range for this position is $62,000.00 - $75,000.00.
#J-18808-Ljbffr