Support the planning, development and implementation of processing for commercial manufacturing. Facilitate the project development process by providing project plans, schedules and supporting documentation to support a potential biological license application (BLA) as well as the potential subsequent pre-approval inspection (PAI) and commercial launch. Support and coordinate efforts with outside vendors to manage reagents and disposables for GMP processing. Manage potential road blocks and proactively resolve problems. Assist in cross-unit coordination both internal and external for clinical and commercial projects.
- Project Management – Create and manage project related documentation to sustain new and existing project development efforts enterprise wide. Manage the development and maintenance of detailed timelines across departments. Interact with project staff to define tasks, dates and resources as they relate to the schedule. Set up tasks and sub tasks to ensure appropriate identification and tracking of project priorities and dependencies. Compile, record and distribute status reports and other documentation as well as any potential issues impacting rate-limiting steps or dependencies to ensure expedient resolution. Manage project correspondence, meetings, deliverables and reporting. Ensure compliance with internal program procedures and project control system guidelines. Contribute to improvements to enhance the efficiency and quality of the work performed.
- Scheduling - Create and maintain project and functional team schedules for new or existing development and deployment projects. Develop and maintain project schedules for complex company projects throughout the project lifecycle. Assist with determining the critical path and constraints to determine effect of changes to the schedule and suggest work-around(s). Track schedule progress and task dependencies. Perform schedule analysis in support of assigned programs and projects. Perform schedule variance analysis by comparing baseline to schedule. Assist management understanding of Gantt, milestone charts, and resource information in the schedule. Participate in scheduling status reviews and other meetings.
- Disposable & Reagent Supply Chain – Coordinate with Quality and Procurement to ensure management of outside vendors to ensure delivery of reagents and custom disposables designed for GMP processing. Monitor timelines and activities with these vendors to ensure supplies support process development and comparability study efforts and regulatory submissions.
- CMC BLA Requirements – Work collaboratively with Quality Control, Quality Assurance, Manufacturing, Validation, Analytical Development, and Regulatory personnel to monitor progress on activities required for the CMC BLA submission (e.g., raw materials program and analytical method validation) to ensure timelines are maintained.
- Regulatory – Work collaboratively with Quality Control, Quality Assurance, Manufacturing, Validation, Analytical Development, and Regulatory personnel to understand and communicate timelines for required regulatory submission documentation to support regulatory interactions throughout automated commercial manufacturing development and implementation.
- Confidentiality – Ensure that information and documentation pertaining to Argos Therapeutics, Inc. is treated as confidential information and handled appropriately as confidential information.
- Safety – Perform all job functions and responsibilities in a safe and responsible manner. Ensure compliance of co-workers with all safety policies and procedures at all times.
- Other duties as required.
Technical Transfer – Communicate scheduling requirements for the training and technical transfer of automated processing to Manufacturing to support validation efforts and the comparability study.
- Requires a BS degree in a scientific discipline with 4+ years related experience or a MS degree in a scientific discipline with 1+ years related experience
- Project Management experience is required
- Knowledge of GMP processing and BLA requirements is preferred
- Strong knowledge of Microsoft Office programs (Word, Excel, PowerPoint, Project)
- Knowledge of Oracle Primavera and SAP is preferred
- Good interpersonal and communication skills are required
- Flexibility on work schedules and duties
- Ability and willingness to be regularly, predictably and reliably at work