Vice President, Manufacturing

axogen; Vandalia (OH); On-site; USD 180,000 - 240,000; Full time

Job summary

Axogen is seeking a Vice President of Manufacturing to lead Ohio Operations, overseeing startup and scaling of tissue processing and biologics facilities. You will drive continuous improvement, capacity planning, and strategic execution with cross-functional partners to meet aggressive growth and quality goals.

The role requires extensive experience in regulated manufacturing, Six Sigma/Lean, and proven people leadership, with a hands-on, results-driven approach to risk management and

Qualifications

• Minimum 12 years of experience in a related field.
• Bachelor's degree required.
• Experience in medical device or regulated industry.
• Experience leading a manufacturing facility.
• Experience with cGMP and regulatory audits.
• Experience with Six Sigma and lean manufacturing.
• Strong written and verbal communication.
• Proven success in leading large teams and setting direction.
• Ability to plan contingencies and long-term strategy.
• Hands-on, resourceful leader delivering aggressive goals.

Responsibilities

• Start-up and continuous improvement of tissue processing and biologics facility.
• Develop capacity expansion strategies for biologics manufacturing.
• Lead Continuous Improvement and introduce new technologies.
• Participate in equipment spec and procurement to ensure cgmp compliance.
• Partner with executives to execute strategic objectives for growth.
• Lead Site Leadership Team with clear objectives and accountability.
• Manage KPIs for Safety, Quality, Delivery, Productivity, and Morale.
• Recruit and develop a high-performance operations team.

Skills

Leadership

cgmp expertise

FDA audits

Six Sigma

Lean manufacturing

Strategic planning

Risk assessment

People leadership

Communication

Budget & finance

Education

Bachelor's degree

Job description

Why you'll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients' lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Vice President, Manufacturing

The Vice President, Manufacturing is a key member of the Axogen Senior Leadership Team with responsibility for leading Ohio Operations. The Vice President, Manufacturing will oversee and be responsible for all facets of the Ohio operations which include strategic guidance on project leadership, budget and finance management, creating hiring and development plans, continuous improvement, succession planning, and strategic plans to accommodate projected growth, to include planning for updates to partner groups Quality, Regulatory Affairs, EHS, IT, and human resources. The Vice President, Manufacturing/Processing will report to the Vice President, Operations.

Requirements of the Vice President, Manufacturing

• Minimum 12 years of experience in a related field
• Bachelor's degree
• Experience within medical device, tissue, biologics or other regulated industry
• Experience leading a manufacturing facility
• Must have operated within a cGMP facility
• Experience with FDA and/or other regulated audits
• Experience with Leading and Implementing six sigma and lean manufacturing
• Strong written and verbal communication
• Must have proven success in leading large teams and including people leaders to set clear direction, solve problems, and partner with counterparts while also challenging the status quo.
• Must have proven success in proactive approach for contingency planning and long-term strategic planning.
• Must have experience and demonstrated ability to build and lead strong action-oriented teams to deliver results.
• Ability to assess risk and recommend and drive progress and decision.
• Must be hands-on, resourceful, ability to effectively manage and lead resources to deliver on aggressive goals and objectives within the company.
• Strong operations leadership of a business unit/plant and process.

Responsibilities of the Vice President, Manufacturing

• Start-up, maintain, and continuously improve operations of a new tissue processing and biologics facility while ensuring adherence to Biologic and Tissue processing facility requirements.
• Develop and execute capacity expansion strategies for biologics manufacturing operations, improving operational performance, resource utilization, and scalability while maintaining compliance within a biologics framework
• Lead effective Continuous Improvement by challenging existing assumptions and introduce innovative technologies, operating practices, and business processes that improve quality, productivity, capacity, and employee engagement. Identify and prioritize through resource management strategic plans, key goals, and objectives along with day-to-day operational requirements.
• Participate in the specification and new equipment purchase to assure compliance with cGMP standards and regulations and fits within operational needs.
• Partner with executive and functional leaders to establish and execute strategic objectives that support company growth and operational excellence.
• Lead the APC Site Leadership Team to ensure clear objectives, direction, support and feedback to include accountability across all processing, engineering, material handling, and quality areas.
• Manage operational KPIs for Safety, Quality, Delivery, Productivity/Cost and People/Moral.
• Attract, recruit, retain, m