Manufacturing Project Coordinator II

Manufacturing Project Coordinator II

As a Manufacturing Project Coordinator, you will serve as a liaison between the manufacturing team and the project management team to assure all manufacturing related activities and expectations are communicated to the direct manufacturing team. The coordinator acts as the manufacturing representative on cross functional project teams and communicate the relevant information required to successfully execute a manufacturing campaign (with focus on "best view projects" as well as more complex "non-standard" projects).

Key Responsibilities:

• Originate or coordinate the revision, approval, and/or review GMP documentation including but not limited to:
  Process Instructions, Standard Operating Procedures, Change Controls, and Planned deviations
• Complete tasks in SAP system (including generation of product item numbers / entering raw materials required for a campaign etc)
• Review project specific documents including but not limited to:
  Manufacturing Process Outline (MPO) and Manufacturing Process Formula (MPF)
• Train manufacturing staff on project specific details
• Train team members to complete tasks relevant to the job (per job description)
• Communicate project details and status to Manufacturing Management Staff
• Responsible 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
• Support Continuous Improvement Projects
• Represent Manufacturing on Project Teams, communicating and delivering project expectations
• Attend daily/ weekly internal and external customer meetings to report manufacturing updates
• Keep detailed records of project campaigns
• Assist in technical and safety risk assessment and communicate any risks to the manufacturing team
• Assist in project specific compliance investigations
• Interact with various functional groups and the customer to accomplish project goals
• Work with the project managers and customers to resolve Manufacturing specific questions and Process Instruction comments

Required Skills/Abilities:

• This is specialist position requiring a comprehensive knowledge of the cGMP requirements for pharmaceutical manufacturing or API manufacturing
• Minimum education requirements include a science related Bachelor's degree or equivalent work experience
• Knowledge of biotechnology/ chemical manufacturing processes and equipment is preferred
• Knowledge of oligonucleotide chemistry is preferred
• Must have proficiency using basic computer tools like Word, Excel, MS Project or equivalent programs
• Excellent written and verbal communication skills
• Experience dealing with internal and external customer
• Employee must be able to directly interact with various functional groups and clients

The annualized salary range for this position is between $75,400.00 - $92,300.00.