Associate Director, Diagnostics Manufacturing

Reporting to

Sr. Vice President, Head of Diagnostics

Location

Qualigen Therapeutics, Inc.
2042 Corte del Nogal, Suite B
Carlsbad, California 92011

Number of Reports

Number of Direct Reports: 7, Number of Indirect Reports: 8

Purpose of the Role

Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack ® System, which has been used successfully in diagnostics for over 20 years. The Associate Director of Manufacturing is responsible for the manufacturing, engineering, planning, scheduling, purchasing, shipping/receiving and warehousing functions in the production of FastPack diagnostic products in alignment to the business model. This leader will provide plans for operations management and development based on business goals. Support Head of Diagnostics in strategy development and continued operational effectiveness and efficiencies.

The Associate Director of Manufacturing will partner with, and present to the management team the requirements for production and supply chain processes, as well as plan, direct, and coordinate activities in the production of Fastpacks, analyzers, other equipment, and consumables. This position reports directly into the Sr. Vice President, Head of Diagnostics. Provide Engineering support for maintaining and improving products and manufacturing equipment. Maintains an efficient, cost-effective operation. Proactively plans for future requirements, oversees, captures in Smartsheet, and presents project management activities.

Success of this position relies on understanding operations, manufacturing, engineering, and quality requirements for the in vitro diagnostics industry. Must be able to translate project development activities into operational terms and define future requirements based on forecasts and business goals.

Main Interfaces

Internal: SVP, Head of Diagnostics, Direct and indirect Reports, Management team, including Chief Scientific Officer, CEO, President, CFO
External: Contractors and Suppliers

Key Tasks & Responsibilities

  • Establishes, documents, implements, and communicates the strategic direction of the organization’s manufacturing and supply chain activities. Continuously evaluates resources (personnel, time, space, etc.) for current and future needs.
  • Collaborates with senior leadership to develop and meet company goals while leveraging expertise in manufacturing and engineering projects and systems. Evaluate needs and provide recommendations for future growth based on forecasts, cost, and business goals.
  • Ensures that departmental decisions and project plans such as those for staffing, development, material efficiency, parts acquisitions and facilities are in line with the business plan and vision
  • Establishes, communicates, and implements manufacturing and engineering policies, practices, and standards measures to ensure effective and consistent support and execution
  • Lead and manage manufacturing and materials teams as well as engineering needs. Develop teams to exemplify operational excellence. Foster an atmosphere of teamwork through employee collaboration and informing solutions with team member ideas and frequent involvement.
  • Develop personnel to achieve required quality levels for products and processes. Ensure appropriate cross training to minimize schedule disruptions, as well as product availability.
  • Identify training needs for the team and ensure proper training is available and provided
  • Oversee planning processes including MRP and manufacturing schedules in support of on-time deliveries. Evaluate resources to ensure schedules can be met, including implementing overtime when necessary.
  • Oversee purchasing of materials for building product to plan and specifications. Ensure vendor selection meets quality requirements.
  • Ensure manufacturing of products is done according to QSRs and all documentation meets quality requirements. Establish and maintain manufacturing processes to ensure compliance with the quality system as well as product quality.
  • Build plans to update manufacturing equipment and processes to meet opportunities or threats to the company. Develop engineering plans to improve reliability and reduce common issues.
  • Implement efficient workflows and determines capital purchases to ensure goals are achieved
  • Maintain the facilities and manufacturing/warehousing equipment through vendors or internal support. Evaluate needs and provide recommendations.
  • Inventory Management: proactively plans for sufficient inventory and preventing backorders to best extent feasible
  • Support safety coordinator for the company. Provide necessary training and procedures for safety requirements for the company.
  • Provide technical and engineering support and resources to other teams (Quality, Finance, Customer/Technical Service, etc.) to carry out the organization’s goals and objectives. Work with other departments to improve efficiency and troubleshoot and eliminate common problems without effecting quality.
  • Work with QA to ensure team is maintaining compliance and is ready for audits. Participate in customer complaint resolution.
  • Anticipate and deliver on time and within budget in support of achieving business and operational goals
  • Develop and communicate metrics to support overall direction for planning and monitoring of achieving goals
  • Maintain knowledge of emerging technologies and trends in IVD manufacturing

Education

  • Bachelor’s degree – Mechanical or Biomedical Engineering – required
  • Certifications in areas of Operations strongly preferred (APICs, Lean Six Sigma, AMA, Operational Management, etc.)

Professional Skills & Experience

  • 6+ years in the medical diagnostics industry
  • 4+ years leading/managing teams
  • Extensive knowledge of the principles, procedures, and best practices in the diagnostics and/or biotechnology industry
  • Experience leading manufacturing teams
  • Knowledge of diagnostics engineering, manufacturing, materials management, & purchasing
  • Experience optimizing workflows, operational efficiencies, cost reduction, and improving quality
  • Ability to drive process improvement
  • Experience managing complex manufacturing line equipment
  • Proficient in using ERP/MRP systems and Microsoft Office Suite or related software
  • Strong analytical and troubleshooting skills
  • Highly organized; must be able to handle many disparate activities seamlessly
  • IVD manufacturing knowledge required
  • Understanding of ISO13485 and FDA QSR compliance required
  • Excellent communication skills. Able to work with a variety of people in different departments.
  • Experience making presentations to management, project teams, and subordinates

Personal Skills & Competencies

  • Strong leadership and supervisory skills; able to improve employee satisfaction and provide direct guidance to subordinates.
  • Customer oriented and demonstrated excellent oral and written communication skills with the ability to be persuasive and compassionate
  • Able to use a scientific, data driven approach to decision making
  • Strong organizational, analytical, and problem-solving skills with an attention to detail
  • Ability to foresee potential obstacles with schedules or tasks
  • Strong business acumen with a broad understanding of fundamental business principles
  • Critical thinker who demonstrates positivity, grit, and solution-orientated approach
  • Able to reason independently to assess issues and solutions
  • Strong interpersonal skills with ability to collaborate and build a consensus
  • Ability to function with minimal supervision
  • Builds and maintains a positive working relationship with key stakeholders and team members
  • Motivate others and self
  • Engenders trust in others and demonstrates integrity

Candidates must be located in the Greater San Diego area and work on-site in Carlsbad.
Relocation assistance not available.
Candidates must be authorized to work in the U.S..
Candidates must be available M-F 40 hours/week.
Candidates will be eligible for benefits.
Travel may be required. Exact amounts of travel will vary.
Qualigen Therapeutics is an EEO employer.

Please forward CV, resume, and correspondence to careers@qualigeninc.com