Job Description

Assignment Duration: 1 Yea

Location: Upper Merion, PA

Two (2) Postitions Available 

Description:

• Responsible for extraction, compilation, and verification of manufacturing and product quality data. May author manufacturing data reports for Biopharm assets progressing within the R&D portfolio. Will have access to data repositories and an understanding of GMP documentation systems and requirements.
  
  
• Coordinates activities with Development groups, including requests for manufacturing performance and product quality data. Will represent the Process Technology Department at multi-disciplinary matrix teams. Presents status updates on documentation progression at these meetings.
  
  
• Responsible for ensuring that manufacturing campaign data, supporting information, and reports are accurate and fit for purpose to support regulatory submission authoring.
  
  THE SPECIFIC DUTIES OF THE ROLE/POSITION:
  
  
• Accesses GMP data repositories to extract and compile data for publication in a controlled document system. Verifies the data against original sources and prepares data reports.
  
  
• Prepares documents and data summaries for use in technology and knowledge transfer. May conduct data verification for regulatory submissions. Ensures that documentation is sufficient to support regulatory submission authoring.
  
  
• Coordinates data transfer activities between various Biopharmaceutical Development and Supply groups. Represents the Process Technology Department in multi-disciplinary matrix teams. Presents results/conclusions and contributes to the decision-making process within these teams.

COMPETENCIES:

Knowledge, skills, and behaviors required to fulfill specific duties of Role/Position

• B.S. Degree
• Experience with data management software and controlled documentation systems. Proficient in MS Word and Excel.
• Good written and oral communication skills.
• Good organizational, collaboration, and teamwork skills.
• Strong interpersonal skills. Reliable team player able to function within a collaborative- and team-based organization.
• Experience in project management and delivery, including the ability to prioritize and progress courses of action.

• Works independently with minimal to no direct supervision.
  
  
  PREFERRED COMPETENCIES:
  
  
• Previous experience in a manufacturing role, including familiarity with batch records and electronic data systems.
• Knowledge of cGMP requirements for documentation and data handling.
• Experience in Bioprocessing