Groton, United States
11 months ago
Project Specialist- Long term contract with benefits!!
Seeking a highly motivated individual for the role of Project Specialist within the Drug Product Manufacturing group. Manufacturing facilities utilize advanced manufacturing technology to produce clinical supplies for Phase I – III studies. The selected candidate will support the team by developing and maintaining the documentation required to produce solid dosage forms, following Good Manufacturing Practices (GMP). The candidate will author and review GMP documents to ensure the highest quality from a technical, regulatory, and compliance perspective (e.g., batch records, procedures, and logbooks). The candidate will help schedule manufacturing activities for the group. The candidate may also assist in building informatics capabilities to standardize workflows, capture lessons learned from manufactures, aide in scheduling of manufactures, build metrics to highlight our productivity, and facilitate training programs.
Provides support in authoring and editing of batch records for clinical and non-clinical drug product manufacture.
- Assists Drug Product Manufacturing (DPM) Leads in coordinating drug products to be manufactured.
- Create/review GMP documentation, including batch records, product specific cleaning assessments, and procedures (formatting, editing, reviewing, workflow management).
- Assists DPM Leads with scheduling of activities and project management.
- Follows relevant procedures and GMP guidelines.
Ensures comprehensive reviews for various types of clinical and non-clinical manufacturing documentation to achieve the highest quality from a technical, regulatory and compliance perspective.
- Responsible for data review, batch record documentation, and document review/approval processes in collaboration with DPM lead.
- Identify and raise quality and safety issues to appropriate teams(s) for resolution.
- Provide customers and support groups with real time project status updates as needed.
- Maintain and archive various GMP logbooks for the SDM group.
Support of Manufacturing schedules in Clementine
- Manage the allocation of new projects in clementine
- May liaise with Supply Chain Leads and Master Planner
- Maintain up to date weekly manufacture schedule
- Understanding of equipment availability and capacity to enable manufacturing schedule
- Coordinate with Operations and Technical Support group to enable manufacturing schedule
Support knowledge management activities
- Assist the implementation of informatics capabilities, such as electronic logbooks and batch record system.
- Help document key process learning/observations to share with partner lines.
- Document non-clinical data in support of development work within electronic lab notebook (eLN)
- Update team SharePoint site as a source of real time information for our group and partner lines
- Willingness to learn software applications in support of project management, procurement, document management, scheduling and metrics.
- Support documentation associated with our department training program.