Manager, Production

Key Duties

• Has direct supervisory authority over the entire Sensor Assembly, Kit Assembly and Analyzer Assembly area personnel.
• Assists Senior Management in developing short- and long-term goals and objectives.
• Provides suggestions and recommendations.
• Plans, prepares, issues, and controls production schedules and directs material requirements to ensure a controlled flow of raw materials timed to meet production requirements.
• Creates weekly production schedules for internal work centers.
• Analyze daily capacity constraints and effect necessary adjustments to resources.
• Monitor actual production and compare to schedule.
• Work with production and quality personnel to resolve on hold or potential scrap inventory issues in a timely manner.
• Provides direction and daily communication on certain production issues.
• Is a key member of the leadership team at the site and will participate/attend key planning meetings and regular updates to develop and execute the roadmap for the site.
• Participates in development of policies and procedures to ensure that they support and complement company-wide strategic objectives.
• Conducts periodic reviews of existing policies and procedures to ensure effectiveness.
• Ensures that policies and procedures are updated in accordance with evolving production and quality standards.
• Assists Senior Management with startup and integration of new products.
• Covers production schedules and to ensure that product is available and meets customer needs.
• Assists with investigations and root causing problems and product inconsistencies.
• Ensures that production functions are completed in accordance with established GMP, production, safety and quality standards.
• Works closely with Purchasing and Quality Control departments to maintain schedules and meet deadlines.
• Provides assistance and support to related departments as required.
• Keeps management informed of area activities and significant concerns.
• Ensures work areas and equipment are clean, safe and well maintained.
• Captures and directs continuous improvement initiatives for all manufacturing areas, leveraging lean tools and methodologies.
• Affirms strong leadership, team building and organizational skills.
• Strong attention to detail.
• Ability to analyze processes for compliance, determine and communicate vulnerabilities.
• Strong problem-solving ability.
• Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.

Qualifications

• Bachelor of Science (BS) degree is highly desirable, high school diploma or general education degree (GED) is required.
• Strong knowledge and work experience in an FDA regulated environment.
• Experience in scientific/manufacturing principles associated with product design, development and manufacture in GLP and GMP environments is required.
• A minimum of five years of supervisory experience is required.
• Experience operating and troubleshooting packaging and/or manufacturing machinery is required.
• Demonstrated strong leadership, team building and organizational skills.
• Strong attention to detail.
• Ability to analyze processes for compliance, determine and communicate vulnerabilities.
• Strong problem-solving ability.
• Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.