Assignment Duration: 1 Yea
Location: Upper Merion, PA
Two (2) Postitions Available
- 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.
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.
- 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