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Process Development Associate 4

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Manufacturing Operations
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JOB SUMMARY
 
Responsible for assisting in the support of launched/approved products and operations processes and the creation and transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes.                                                                                                                                                                                                               
 
Responsible for the development of new processes, transfer to manufacturing and continuous improvement of existing processes.  Provide process support to Manufacturing and other Operations Groups. Responsible for Pilot & Development Manufacturing activities.
 
ROLE ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Leads execution of process validation of new and existing manufacturing processes
  • Assists with troubleshooting experimentation required for projects.
  • Troubleshoots simple manufacturing process problems.
  • Assists in the development of manufacturing processes for transfer to Manufacturing.
  • Aids in the design of new qualification protocols.
  • Trains others on newly developed procedures.
  • Support the Technical Writers by contributing to manufacturing work instructions, area guidelines, knowledge base topics, style guides/templates, & department SOPs.
  • Independently originates simple to moderate difficulty CCRs
  • Independently produces notebook, pilot and production materials
  • Creates Dev Docs and assists with assembly of change control packages.
  • Keeps accurate records and documentation.                                                                              
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
EDUCATION AND EXPERIENCE
  • Typically requires BA or BS and 2-5 years related experience desired or MS with 0-1 years’ experience desired
  • Working knowledge of experimental design
  • Knowledge of current GMPs
  • Blood Borne Pathogen training
  • Interpersonal skills
  • Technical skills
  • Work under own initiative and uses own judgment
  • Works collaboratively
  • Builds working relationships
  • Problem Solving
  • Proficiency with MS Word and Excel
  • Strong math skills
  • Applied knowledge of Technical writing
  • Basic presentation skills
PHYSICAL DEMANDS 
 
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Regularly required to sit.
  • Regularly required to use a computer keyboard, mouse, and monitor. 
  • Regularly required to talk and hear. 
  • Occasionally required to walk to meeting locations. 
  • Required to use close vision and adjust focus. 
WORK ENVIRONMENT 
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Work is performed primarily in an office environment
  • There will be a requirement to work within a laboratory environment

ACCOUNTABILITY

  • Actions taken by employees in this position have financial impact on end results of the department and the company

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