Director of Manufacturing Operations

POSITION SUMMARY The Director of Manufacturing Operations will be responsible for overseeing procurement, fulfillment, raw material & finished goods inventory, production planning, and daily manufacturing operations. This includes managing production, ensuring quality standards, and optimizing efficiency. The ideal candidate will have a strong background in supply chain management, with the ability to integrate and oversee the entire supply chain process, from procurement to distribution. ESSENTIAL JOB FUNCTIONS · Oversee day-to-day manufacturing operations, ensuring production schedules are met · Implement and maintain efficient manufacturing processes and workflows · Set clear performance goals and expectations for site manufacturing. Monitor and analyze production metrics and KPIs to ensure goals are met or exceeded and drive transformational improvements on a regular basis · Ensure that all manufacturing activities adhere to regulatory, safety and quality standards, consistently championing this culture within the organization. · Collaborate with cross-functional partners in support of new product development efforts required to integrate new technologies · Provide input to and implement operational and financial goals and objectives for the manufacturing area assigned. Track and trend performance levels and maximize operations. · Recommend and implement ideas to reduce costs, adapt and transform the organization to meet changing business needs · Assist teams in troubleshooting manufacturing issues. Ensure staff is provided technical knowledge and training to efficiently produce the highest quality products · Collaborate with peers and cross-functional partners such as Engineering and Quality to ensure seamless operations and quality improvements. Synthesize action plans, timelines and budgets to meet project and product goals · Develop and manage staff through hiring, managing performance, developing talent and providing clear expectations · Responsible for completing established goals, prioritizing project work and controlling and coordinating all activities and improvement efforts across manufacturing areas · Optimize inventory levels to meet production demands while minimizing carrying costs · Coordinate with logistics to ensure efficient and timely delivery of finished goods to customers · Foster a culture of continuous improvement and accountability · Identify opportunities for process improvements and implement Lean Manufacturing and Six Sigma principles · Drive initiatives to reduce waste, increase efficiency, and improve product quality · Develop and manage the manufacturing budget, ensuring cost-effective operations · Monitor expenses and implement cost-saving measures without compromising quality or safety · Ensure all products meet quality standards, product requirements and customer specifications · Implement and maintain quality control processes and procedures · Knowledge of best practices in regulated diagnostics production environments · Technology implementation and knowledge of the latest manufacturing technologies and automation systems to enhance productivity, quality and scalability · Effective and timely communication to leadership regarding manufacturing progress, blockers, and proposed solutions · Ability to establish/demonstrate manufacturing process/equipment capabilities and drive manufacturing development for new product development · Establish, manage, and complete design transfer activities for new product development · Manage the Master Validation Plan for manufacturing · Manage equipment calibration and preventive maintenance schedules SKILLS AND ABILITIES · Strategic planning to develop and execute growth strategies that align manufacturing operations with business objectives and new product introductions · Risk management to identify and mitigate risks associated with scaling operations · Proven experience in supply chain management, including procurement, inventory management, and logistics · Strong knowledge of Lean Manufacturing, Six Sigma, and other process improvement methodologies · Strong working knowledge of industry regulations and legal guidelines (e.g., FDA 21 CFR Part 820, ISO 13485 and ISO 14971, GMP, GDP, GLP etc.) · Excellent leadership and team management skills with the ability to develop professional growth for the team · Strong analytical and problem-solving abilities to interpret production data and trends then model future scenarios · Proficiency in Oracle NetSuite ERP software · Excellent organization, collaboration, communication and interpersonal skills for both internal cross functional and external stakeholder engagement · Excellent attention to detail · Familiarity with Lyopholization processes · Familiarity with Medical Device Production · Familiarity with Medical Device Consumable Production MINIMUM REQUIREMENTS · Bachelor’s degree in engineering, Manufacturing, Supply Chain Management, or a related field · 10 years of experience managing manufacturing operations within a regulated environment such as complex medical devices, IVD consumables, electronics instrumentation, and/or pharmaceuticals PREFERRED REQUIREMENTS · IVD/complex medical device experience strongly preferred · Experience managing manufacturing operations for products with large amount of custom components · Experience with automated and semi-automated manufacturing equipment · Master’s degree in related field

Location: Philadelphia, PA, US

Posted Date: 6/14/2025