Director of Manufacturing Astute Medical, Inc.
THIS JOB HAS EXPIRED Job ID#: 55121
Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Director of Manufacturing. The Director of Manufacturing will provide hands-on leadership in coordinating and managing the day-to-day manufacturing of Astute Medical?s in-vitro diagnostic products. Additionally, this position will work closely with executive management to expand Astute Medical?s manufacturing activities. The ideal candidate will apply their strategic thinking, communication, and negotiation skills to ensure the company?s manufacturing capabilities exceed industry standards, regulations, and customer requirements.
Assist executive management in the development and implementation of short and long-range plans, policies, programs, and goals related to expanding production capacity, facilities, and manufacturing operations.
Actively manage on-going relationships with contract manufacturers and other key suppliers to ensure Astute Medical?s expectations for product quality, cGMP compliance, costs, inventory, production planning, and schedule are clearly understood and consistently met.
Ensure personnel, equipment, and material resources are aligned with and capable of supporting production plans and inventory goals.
Hire and develop staff to support production plans.
Develop, implement, and maintain systems, standard operating procedures, and best practices for global manufacturing considering future company growth, continuous improvement, and compliance with quality as well as regulatory standards.
Implement Company?s Quality Management System to ensure that high quality standards are maintained. Ensure that all individuals reporting to him/her comply with the Company?s Quality Management System.
Partner with key suppliers and functional areas throughout the company to continuously track and improve product quality and manufacturing efficiency. Provide support in the following areas to ensure continuous improvement.
o Product Complaints and Investigations
o Collection and interpretation of product metrics
o Product design and process changes
Participate in the development of new products and manufacturing processes. Provide support in the following areas during the transfer of new products and processes to manufacturing.
o Materials and Production Planning
o Risk assessment
o Equipment and Process Validations
Bachelor?s, Master?s, or Doctorate degree in a scientific or engineering discipline
10+ years of progressive experience in a manufacturing environment within the in-vitro diagnostics, medical device, or related industry. A minimum of 5-years experience leading a significant segment of a large manufacturing organization or the entire operation of a smaller organization, ideally in a rapid growth environment.
Must have broad knowledge and proven working experience with good manufacturing practices, including a thorough understanding of the following areas:
o Industry practices for design change and transfer
o Inventory planning, forecasting, supply chain, and control
o cGMP, ISO 13485 and 21 CFR Part 820
Ability to work effectively with cross-functional teams as well as external corporate partners. Experience with managing external contract manufacturing organizations preferred.
Strong, energetic leader, coach, and mentor with a demonstrated track record of success deploying new products into high volume production.
Excellent organizational and project management / leadership skills with a proven ability to effectively plan and conduct programs across multiple functional areas.
Travel: must be willing to travel up to 50 percent of the time
||San Diego, CA |
THIS JOB HAS EXPIRED