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Responsible for supervision of the implementation and maintenance of manufacturing methods, processes and operations for new and existing products and technologies. Ensures the effective use of materials, equipment and personnel in producing quality products. Assist with the development and management of budget. Formulate and recommend manufacturing policies, procedures, and programs.

Manufacturing Operations Work on problems of moderate scope where analysis of situation or data requires a review of identifiable factors. Exercise judgment within defined procedures and policies to determine and implement appropriate action. Act as an advisor to Molecular Biology (RNA) production group, being actively involved in the production of therapeutic grade material, production planning and resolving problems. Interact with subordinates, outside customers, and functional peer groups at various management levels. Act as the representative for respective manufacturing group on project teams. Actively participate with the transfer and implementation of new processes and procedures into the manufacturing process from the development and research groups. Compile and present technical information concerning specific projects/schedules, etc. Ensure that all systems associated with the Molecular Biology (RNA) production processes/areas are validated at all times.
Documentation Ensure that all production related documents are completed and reviewed at the highest standards according to company and governmental GMP regulations, policies and procedures. Assist with outlining, writing and reviewing validation protocols, reports and the production related sections of regulatory submissions (IND, BLA, Amendments, Updates, etc.) Ensure that Process Flow Diagrams (PFDs), Facility Flow Diagrams (FFDs), Standard Operating Procedures (SOPs), etc. accurately represent the flow of product, materials, and personnel within the production areas.
Supervision Provide general or direct supervision to exempt employees and/or skilled non-exempt employees. Ensure objectives of subordinates are current and evaluate subordinates performance with respect to assigned objectives and that they follow all company procedures at all times. Facilitate training of new employees and ensure that training documentation for self and subordinates is current and complete.
Safety Perform all job functions and responsibilities in a safe and responsible manner. Ensure compliance of subordinates and colleagues with all safety policies at all times.
Confidentiality Ensure that information and documentation pertaining to Argos Therapeutics, Inc. is treated as confidential information and handled appropriately as confidential information.
• Other duties as required.

• Bachelors degree in a scientific field and at least four years of relevant supervisory/leadership experience in an FDA-regulated industry required.
• Experience in all aspects of GMP manufacturing/production processes required.
• Experience with MS Word and Excel required. Experience with VISIO, Project, and Access preferred.
• Experience with technology transfer, technical writing, process optimization, supervision/leadership and training required.

We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please a resume with a cover letter and salary history.

Argos Therapeutics is an Equal Opportunity Employer.