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 Manufacturing Director.
This individual will be responsible for and direct the clinical and commercial manufacturing activities of Argos Therapeutics.
- Clinical Manufacturing – Manage all aspects of GMP manufacturing processes for producing autologous cellular products for phase 2 and phase 3 clinical studies. Manage a highly productive, timeline directed, objective oriented cohesive team to meet clinical manufacturing objectives. Develop production budgets for the clinical trials including the timelines for achieving their endpoints in collaboration with the Clinical group. Coordinate scheduling of manufacturing with clinical research. Ensure that manufacturing processes comply with appropriate FDA, Health Canada, and EMA regulatory requirements. Maintain and improve manufacturing procedures, electronic batch record master recipes, PFDs, and SOPs. Coordinate and approve validation activities for manufacturing operations to support clinical manufacturing. Ensure manufacturing operations are capable of meeting clinical production demands in terms of manpower, facilities and process improvements. Support QP audits and manufacturing for clinical trials in Europe.
- Commercial Manufacturing – Assist the Facilities group in the selection and design of a commercial manufacturing facility. Develop and plan automated commercial facility expansions for manufacturing in conjunction with Facilities group that meet FDA, Health Canada, and EMA regulatory requirements. Develop manufacturing flow and methods to ensure manufacturing demand is met in the new automated commercial manufacturing facility. Coordinate and approve validation activities for manufacturing operations to support automated commercial manufacturing in the new facility. Ensure manufacturing operations are capable of meeting commercial production demands in terms of manpower, facilities and process improvements. Support regulatory audits for commercial manufacturing.
- Management – Assist the COO/VP Manufacturing in the strategic planning and execution of the corporate goals for the Operations organization (QC, QA, Materials Management) including the resources and timelines for carrying out those objectives. Formulate, monitor and control budgets, manpower and capital expenditures. Work as an effective team member with others in Executive Management, Operations and R&D to identify and accomplish company objectives.
- Supervision – Provide direction and objectives to managers and supervisors in Manufacturing. Provide general or direct supervision to exempt employees and/or skilled non-exempt employees. Support employees during manufacturing activities. Evaluate subordinates’ performance with respect to both behavioral and work performance, assigning objectives and ensuring that these objectives are current. Ensure that subordinates follow all SOPs and company procedures at all times. Facilitate training and qualifications of new employees, making certain that cGMP training for self and subordinates is current and complete.
- Confidentiality – Ensure that information and documentation pertaining to Argos Therapeutics, Inc. is treated as confidential and handled accordingly. This includes protecting Argos trade secrets.
- Safety – Performs all job functions and responsibilities in a safe and responsible manner. Ensures compliance with all safety policies and procedures at all times.
- Other duties as required.
- Advanced scientific degree or equivalent and experience in FDA, Health Canada and European regulatory compliance for cell-based therapies, with at least 10 years experience in the manufacture of cell biologicals, preferably patient specific cell therapeutics, supervision and budgeting.
- Demonstrated ability to formulate, implement and manage complex GMP manufacturing processes for clinical and commercial applications. This includes knowledge in GMP facility planning and construction to meet technical and regulatory requirements.
- Expert knowledge in cGMP compliance for commercialization of biologicals is required, and knowledge of molecular biology, primary cell biology and immunology is desired.
- Experience with multiple autologous, personalized vaccine processes that can be reproducibly manufactured for clinical and commercial applications is preferred.
- Knowledge of JIT manufacturing, scheduling of production, and automated equipment for cellular processing.
- Knowledge and know-how to decrease cost of manufacture and arrive at profitable COGS for the commercial product, especially for complex personalized immunotherapies.
- Experience managing outside contract manufacturing groups and production activities.
- Strong interpersonal skills and demonstrated ability to communicate with a diverse team to bring about successful product release from production activities a must.
- Must have the ability to communicate effectively with all levels of management and bring knowledge and experience related to the responsibilities of this position to the activity of strategic, tactical and budgetary planning.
- Strong leadership skills and the ability to successfully operate in a team environment with commercial goals and high level of focus on objectives.
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.