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 Validation Project Manager.
Manage projects to ensure commissioning, qualification and validation efforts for equipment, facilities, utilities, process control systems, computer systems, disposables, methods, and process validation are completed as required to support clinical and commercial manufacturing and regulatory submissions, including biological license applications. Organize multi-functional activities to ensure completion of project(s) while adhering to schedule requirements.
- Project Management – Develop and maintain detailed timelines for the commissioning, qualification, and validation projects for clinical and commercial manufacturing in a new facility currently under construction. Manage proposals and activities of outside consultants responsible for planning and executing validation activities. Manage budgets and resources to ensure projects remains on schedule. Create project plans, schedule, analysis and reports as necessary. Communicate progress and costs to directors and executives as well as any potential issues impacting rate limiting steps or dependencies to ensure expedient resolution.
- Commissioning, Qualification, and Validation – Work collaboratively with Commissioning, Validation (includes Utilities, Equipment, and Computer System Validation), Methods Validation, and Process Validation personnel to ensure requirements, dependencies, and timelines for projects are understood and coordinated. Coordinate requirements, validation master plans, risk assessment, protocol and SOP developments to support all validation activities. This includes ensuring validation activities are coordinated with expected FAT and SAT timing. Define scope of work, project plans and deliverables with extensive vendor and resource management.
- Systems Integration – Work collaboratively with the Automated Manufacturing and Operation Systems Project Managers and system integration personnel to ensure requirements and timelines for integrating projects are communicated and managed effectively to support validation efforts.
- Regulatory – Work collaboratively with Quality Control, Quality Assurance, Manufacturing, Facilities and Regulatory personnel to understand required regulatory submission documentation and communicate any potential impact to timelines based on validation project efforts.
- 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 or engineering discipline with 8+ years related experience or a MS degree in a scientific or engineering discipline with 5+ years related experience
- Project management experience is required.
- Familiarity with commissioning and validation concepts, procedures, protocols and requirements to support GMP is required.
- Good interpersonal and communication skills are required.
- Excellent decision making and creative problem solving skills.
- 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.