Director of Manufacturing

TITLE: Director of Manufacturing Operations

DIRECT REPORTS: TBD

REPORTS TO: TBD

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

PHYSICAL DEMANDS

Stand

C

Push/Pull

Walk

C

Under 10 lbs.

F

Sit

O

11-25 lbs.

F

Handling/Fingering

F

25-50 lbs.

O

Reach Outward

F

Over 50+ lbs.

O

Reach Above Shoulder

F

Lift/Carry

Climb

N

Under 10 lbs.

F

Crawl

N

11-25 lbs.

F

Squat or kneel

O

25-50 lbs.

O

Twist

O

Over 50+ lbs.

O

Bend

O

Overhead

Outdoor Environment

N

Push/Pull

O

Office Environment

O

Lift/Carry

O

N (Not Applicable) Activity is not applicable to this occupation.

O (Occasionally) Occupation requires this activity up to 33% of the time (0 - 2.5+ hrs./day)

F (Frequently) Occupation requires this activity from 33% - 66% of the time (2.5 - 5.5+

hrs./day)

C (Constantly) Occupation requires this activity more than 66% of the time (5.5+ hrs./day)

Disclaimer

At Biomeme we believe that every employee should enjoy equal employment opportunity and be free to participate in all aspects of the company. We do not discriminate on the basis of race, color, religion, national origin, age, sex, gender, pregnancy, disability, sexual orientation, gender identity, genetic information, military status, protected veteran status or other characteristics protected by applicable law.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.