ARGOS IS GROWING!
After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include a well-qualified Project Manager to assist with our Commercial Manufacturing Development efforts.
Manufacturing Science & Technology (MS&T) is responsible for developing a commercially viable manufacturing process using custom-designed automated equipment; ensuring this manufacturing equipment is designed, built, and delivered to support clinical and commercial manufacturing goals; ensuring utility, equipment, and computer systems are validated to support use; and ensuring process validation and comparability studies are performed as required. This Project Manager would support these activities and goals.
- Project Management – Support the coordination of the activities of multi-disciplinary teams in the achievement of project objectives and outcomes. Setup of project related documentation and sustain new and existing project development efforts managed or supported by Manufacturing Science & Technology. Support and participate in identification, prioritization and development of project plans. Maintain detailed timelines, project progress, resources and other project metrics. May write and maintain technical specifications. Facilitate the flow of information among team members on assigned projects. Receive and transmit information requiring accurate explanation and interpretation to assigned technical and non-technical audiences. Identify potential issues impacting rate limiting steps or dependencies and leverage knowledge to develop in-depth and expedient resolution. Assist in cross-unit coordination both internal and external for clinical and commercial projects. Contribute to improvements to enhance the efficiency and quality of the work performed.
- Disposable & Reagent Supply Chain – Participate in identifying, evaluating and recommending the selection of vendors for assigned projects. Coordinate efforts with outside vendors to ensure delivery of reagents and custom disposables designed for GMP processing. Ensure validation efforts are complete to support use of disposables in validation efforts and the comparability study and documented to support regulatory submissions.
- Facility – Work collaboratively with Facilities and the commercial manufacturing facility design team to ensure timelines for equipment delivery and validation are aligned with the facility build.
- CMC BLA Requirements – Work collaboratively with Quality Control, Quality Assurance, Manufacturing, and Regulatory personnel to monitor progress on activities required for the CMC BLA submission (e.g., raw materials program) to ensure timelines are maintained.
- Regulatory – Work collaboratively with Quality Control, Quality Assurance, Manufacturing, Validation 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.
- Requires a BS degree in a scientific discipline with 2+ years of experience in managing technical projects
- Excellent interpersonal and communication skills are required
- Knowledge of GMP processing and BLA requirements is preferred
- Strong knowledge of Microsoft Office programs (Word, Excel, PowerPoint, Project)
- Flexibility on work schedules and duties
We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please submit a resume with a cover letter and salary history.
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.