Manufacturing Director-Class III In vitro Diagnostics - Bratenahl, United States - Cleveland Diagnostics Inc.

Description

Our team is growing, and we currently have an immediate opening for a Manufacturing Director-Class III In vitro Diagnostics

Title: Manufacturing Director

Location: Cleveland office

Job Overview

The Manufacturing Director plays a crucial role in overseeing and optimizing manufacturing processes of Class III In vitro Diagnostics to ensure resources, equipment and facilities are in place to deliver production requirements to support the business need. The Manufacturing Director is responsible for ensuring adherence to all requirements of cGMP and ISO, adequate availability of product, and the effectiveness and efficiency of the production process. Effectively communicates and collaborates cross functionally with Quality Assurance, Research and Development, Purchasing, Sales and Marketing, and Executive Management and outside contract manufactures.

Essential Responsibilities and Duties

• Develop & execute plans and resource requirements to ensure fulfillment of required production per business needs
• Provide oversight of the production process and ensure adequacy for proper regulatory reporting and/or product recalls
• Keep management and quality staff informed of all issues that could interrupt or affect production flow
• Develop & adhere to departmental budget
• Identify, implement & utilize MRP systems to plan & manage production activities
• Implement efficiency improvements & cost reduction efforts consistent with corporate goals
• Proficient use of manufacturing software systems such as MRP, MES, SPC, and Compliance tools
• Ensure compliance to all applicable FDA, ISO, Cleveland Diagnostics' Quality System, safety requirements
• Mitigate any findings related to manufacturing identified through audits, non-conformances, corrective/preventive actions, or customer complaints
• Implement robust manufacturing & kitting platforms for In vitro diagnostic reagents & controls
• Drive continuous improvement initiatives to enhance operational efficiency & productivity; Identify opportunities for process optimization, automation, and cost reduction while maintaining quality & compliance
• Manage supply chain partner relationships including 3rd party contract manufacturers to optimize raw material sourcing, procurement & inventory management; Ensuring timely availability of materials to support production schedules & minimize supply chain disruption
• Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, sales, marketing, finance to support product development, tech transfer, introduction of new products & process improvements
• Utilize statistical methods and data analysis tools to identify trends, deviations & opportunities for optimization/improvement

New Product Introduction (NPI):

• Lead in the development of additional GMP platforms to support product pipeline as they progress in lifecycle stages
• Oversee the development, validation, and implementation of new equipment and workflows for manufacturing. Including: development of protocols, process validation, SOP's and implementation into QMS, and integration into manufacturing department
• Collaborate with cross-functional teams during the development and introduction of new medical devices to ensure manufacturability and scalability
• Develop and execute plans for process validation, ensuring compliance with regulatory requirements and industry standards
• Lead the technical transfer process for new products from R&D to manufacturing department

Laboratory:

• Responsible for maintenance and calibration of equipment
• Ensure manufacturing is in inspection-ready state at all times
• Inventory management of supplies and reagents necessary for manufacturing

Supplier Management:

• Lead the management of contract manufacturers
• Lead/participate in any meetings with suppliers of raw materials and finished products
• Responsible for identifying and vetting potential suppliers
• Assist/participate in audits and inspection of suppliers

Staffing:

• Responsible for hiring, and management of manufacturing employees
• Responsible for scheduling appropriate staffing to meet manufacturing demands

Quality Assurance and Compliance:

• Work closely with quality team to ensure manufacturing processes comply with regulatory requirements, such as FDA regulations (e.g., 21 CFR Part 820) and ISO standards (e.g., ISO 13485)
• Participate in audits and inspections, providing documentation and support and act as Subject Matter Expert (SME) as needed to demonstrate compliance and adherence to standards

Cross-functional Collaboration:

• Collaborate with executive management on key initiatives, develop pathways and timelines for successful completion
• Track/manage, perform, and analyze projects through to completion
• Collaborate with engineering, R&D, quality, and production teams to troubleshoot issues, resolve challenges, and implement process improvements
• Communicate effectively with stakeholders to ensure alignment on project objectives, timelines, and deliverables

Risk Management:

• Conduct risk assessments for manufacturing processes, identifying potential hazards, and implementing mitigation strategies to minimize risk to product quality and patient safety
• Ensure adherence to risk management processes outlined in relevant standards and regulations (e.g., ISO 14971)

Documentation and Reporting:

• Maintain accurate and up-to-date documentation of manufacturing activities, including protocols, reports, and standard operating procedures (SOPs)
• Prepare and present progress reports, data analyses, and recommendations to executive management and key stakeholders

Qualifications

• Bachelor's degree in chemistry, biochemistry, or related field (Masters or PhD preferred)
• Minimum of 10-20 years of experience in manufacturing of Class III In Vitro Diagnostics (IVD), reagent manufacturing preferred
• Strong knowledge of FDA regs (e.g., 21 CFR 820) and ISO standards (e.g., ISO 13485)
• In depth knowledge of manufacturing principles, processes, technologies including Lean Manufacturing, Six Sigma & Continuous Improvement methodology
• Lean and or Six Sigma certification preferred
• Proficiency in Design Control
• Minimum of 5-10 years in a leadership role (e.g., manager, director)
• Experience with process validation and statistical process control
• Excellent communication and leadership skills
• Ability to work effectively in a fast paced and growing early phase org with a cross-functional team environment

Physical Requirements/ Working Conditions/Equipment Used:

• Fine motor skills & manual dexterity to handle specimens/lab equipment required to process specimens & repair equipment
• Visual acuity to examine specimens & reagents
• May be required to stand for long periods of time
• Light lifting may be required; offices reachable by elevator but should be able to climb stairs in case elevator is out
• Heavier lifting may be required (up to 50 pounds)
• General office noise and HVAC
• Ability to operate a computer and other technology related lab equipment through course of day
• May be exposed to hazardous chemicals, biohazards, etc.

Other Requirements

• This is a hybrid position
• This position may require 5-10% travel
• COVID-19 vaccination is highly recommended

Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer.

We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

Cleveland Diagnostics offers an extremely robust benefits package which includes:

• 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
• 100% Employer-paid Dental & Vision for entire family
• No cost for employee coverage for Group Term Life, Short & Long Term Disability
• 4% retirement contribution Employer match
• Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
• Paid Family Leave Program
• Generous PTO plan & holiday program
• Flexible work schedule & lucrative employee referral program
• Salary range may vary by work state/geographical region/territory
• Easy to get to office location with newly built-out office space
• Free coffee, snacks and other goodies all day long

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.

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