East Walpole, United States
over 1 year ago
Key support position being created to support the Technology Transfer Team across multiple pre-commercial projects. Looking for an individual to help create and implement new standard processing techniques across various projects.
Key purpose of this position is to own certain tasks associated with packaging/labeling, clinical trials, and Product Performance Qualification (PPQ)/Design Transfer Lot (DTL) builds. One should be able to independently perform basic tasks and functions for this support role. Drive consistency from project to project. Seek advice and guidance on non-routine or problem areas from others. Identifies problems as they occur and escalates as necessary.
Responsibilities Individual will be specifically responsible for:
- Supporting a team of project managers to meet deadlines.
- Aid in creation or modification of packaging and labeling templates
- Support the preparation of PPQ/DTL builds
- Own preparation for clinical trials
- Track progress of requested and assigned tasks
- Communicate status updates team on a regular basis
- Assist in mapping of current processes and structuring of procedures to reflect process
Required Knowledge/Skills, Education, and Experience
- Education - preference for a degreed applicant with STEM fields
- 2-4 years experience with manufacturing or pre-commercial activities
- Networking, organizational, and excellent communication skills preferred
- Word, Excel, and SharePoint experienced preferred
- Attention to detail; ability to work in GMP/ISO environment
- Strong written documentation of work
- Working knowledge of immunoassay industry is beneficial.
- Product Development experience