AxoGen

Manager, Operational Technology & Manufacturing Systems

AxoGen$113K — $142K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Information Systems, Computer Science, Engineering, Biotechnology, or a related discipline; or 8 years of related experience.
  • At least 7 years of experience in enterprise, manufacturing, operational technology, or regulated systems support.
  • Minimum of 3 years leading technical teams and managing vendor relationships in a manufacturing or regulated environment.
  • Experience with regulated production environments, vendor management, and compliance documentation.
  • Strong communication and relationship management skills, especially with cross-functional teams.
  • Preferred knowledge of GxP regulations, 21 CFR Part 11, and cybersecurity for operational technology.

Responsibilities

  • Serve as the senior onsite IT and Operational Technology leader, bridging plant leadership and corporate IT.
  • Lead and develop the Operational Technology support team, establishing service expectations and workload plans.
  • Oversee maintenance and lifecycle management of manufacturing technology systems, ensuring audit readiness.
  • Direct technology planning for site growth and digital transformation, managing vendor and resource coordination.
  • Partner with cross-functional stakeholders to govern technology changes and maintain compliance across systems.
  • Collaborate with Quality and Corporate IT to uphold GxP compliance and data integrity standards.
  • Establish documentation and governance standards to maintain current and accurate technical records.

Benefits

  • Annual bonus eligibility.
  • Health, Dental, and Vision insurance.
  • Matching 401K plan.
  • Paid Time Off and holidays, including 3 floating holidays.
  • Flexible Spending Accounts for dependent and medical care.
  • Tuition reimbursement for further education.
  • Paid parental and caregiver leave.
  • Basic and supplemental life insurance options.
  • Employee Stock Purchase Plan available.
  • Disability insurance coverage.
Full Job Description
Job Summary of the Manager, Operational Technology & Manufacturing Systems

The Manager, Operational Technology & Manufacturing Systems serves as the senior technology leader for Axogen's Ohio manufacturing facility, providing leadership for onsite technology personnel and acting as the primary liaison between plant leadership and Corporate IT. Reporting to the Senior Director of IT, this role oversees and coordinates Operational Technology, infrastructure, cybersecurity, manufacturing applications, vendors, and enterprise IT resources to ensure reliable operations, regulatory compliance, project execution, and operational excellence. The Manager partners closely with Manufacturing, Quality, Engineering, Facilities, Laboratory, and Operations leaders to align technology priorities with business needs, coordinate activities with production schedules, remove barriers to execution, and minimize operational disruption. The role also leads technology planning team and vendor coordination for facility expansion, workforce growth, infrastructure modernization, and manufacturing system initiatives, ensuring technology capabilities support both current operations and long-term business objectives.

Requirements of the Manager, Operational Technology & Manufacturing Systems
  • Bachelor's degree in Information Systems, Computer Science, Engineering, Biotechnology, or a related discipline; or 8 years of related experience will be considered.
  • Minimum 7 years supporting enterprise, manufacturing, operational technology, computerized, or regulated systems.
  • Minimum 3 years of experience leading technical teams, managing vendor relationships, coordinating cross-functional resources, or directing technology projects in a manufacturing or regulated environment.
  • Experience with regulated production environments, system implementations, vendor management, facility technology, change control, validation support, and compliance documentation.
  • Strong communication, prioritization, relationship-management, and follow-through skills across plant leadership, operational teams, IT, contractors, and vendors.
  • Preferred knowledge of GxP, 21 CFR Part 11, validation, electronic records, manufacturing applications, low-voltage infrastructure, wireless networking, and OT cybersecurity.

Responsibilities of the Manager, Operational Technology & Manufacturing Systems

The specific duties of the Manager, Operational Technology & Manufacturing Systems include but are not limited to:
  • Serve as the senior onsite IT and Operational Technology (OT) leader and primary liaison between plant leadership, Corporate IT, and business stakeholders. Translate operational priorities, risks, strategic initiatives, and business needs into aligned technology roadmaps, support strategies, and execution plans.
  • Lead and develop the OT support team, establishing priorities, workload plans, escalation processes, support coverage, documentation standards, and service expectations while coordinating the efforts of Corporate IT personnel, application owners, vendors, contractors, and site resources regardless of reporting relationships.
  • Oversee operational support, maintenance, and lifecycle management of manufacturing technology systems. Maintain visibility to preventive maintenance, backups, incidents, changes, CAPAs, MOC activities, projects, and support activities, ensuring work is properly prioritized, documented, executed, and audit ready.
  • Direct technology planning and execution for site growth, infrastructure initiatives, and digital transformation efforts. Manage technology vendors and implementation partners while coordinating resources, schedules, dependencies, testing, installations, turnover activities, and technology investments that improve operational efficiency, data integrity, traceability, and business processes.
  • Partner with Production, Quality, Validation, Engineering, Facilities, and other stakeholders to govern technology changes, new system implementations, validation activities, CAPA resolution, and change control processes. Ensure alignment with enterprise architecture, cybersecurity requirements, IT policies, and regulatory expectations while supporting audit readiness and compliance.
  • Collaborate with Quality, Validation, and Corporate IT to maintain GxP, Part 11, data integrity, cybersecurity, disaster recovery, business continuity, and risk management programs across the OT environment.
  • Establish and maintain documentation, governance, and lifecycle standards, ensuring inventories, diagrams, procedures, runbooks, access records, maintenance histories, validation documentation, and technical records remain current, accurate, and audit ready.
  • Manage vendor performance, service levels, budgets, contracts, renewals, capital planning, forecasting, and technology investment priorities in partnership with the Senior Director of IT.

Location

913 Industrial Park Dr, Vandalia, OH 45377

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Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range

$113,903-$142,378 USD

About AxoGen

AxoGen is a leading medical technology company dedicated to peripheral nerve repair. The company's portfolio of products includes Avance Nerve Graft, AxoGuard Nerve Connector, AxoGuard Nerve Protector, and AxoWrap. These products are used in a variety of surgical procedures to repair and protect peripheral nerves. AxoGen's products are designed to improve surgical outcomes and reduce recovery time for patients. The company is headquartered in Alachua, Florida and has operations in the United States, Europe, and Asia.
Learn more about AxoGen
Size
428 employees
Market Cap
$408.8 million
Industry
Net Income
-$23.7 million
Founded
2002
5 Year Trend
+25.4%
Revenue
$112.3 million
NASDAQ

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