axogen · 2 weeks ago
Sr. Scientist, Quality Control
Vandalia, Ohio, United States
Full-time
Onsite
Senior Level
5+ years expAxogen is committed to restoring health and improving quality of life through advanced solutions in peripheral nerve function. The Quality Control Sr. Scientist will provide test method and qualification support, ensuring compliance with applicable standards and regulations while driving process improvements in the QC lab.
BiotechnologyMedicalMedical Device
Responsibilities
Drive completion of OOS investigations and deviations for QC and work with QS to improve investigation module and reports related to all testing completed at APC or contract labs. Partner with Corporate Quality as required
Develop protocols for projects such as method improvements, oversee execution of the protocols, author final reports and manage approval and implementation
Partner with QC Lab Management on ongoing and new process improvements, efficiency improvements, and cross-training. This includes any method validation addendums or improvements
Direct the completion of Qualification and Re-Qualification requirements for QC Lab Instrumentation and new equipment. Contribute to validation planning for new and existing processes, instrumentation, or methods
Manage Commercial stability studies and coordination of sample testing and reports in partnership with QC Manager
Confer with external and internal departments (example Operations, Corporate Quality, Engineering, Regulatory, Quality Assurance, Quality Systems) concerning various projects and actions required
Lead and participate in BLA support including PAI action steps, audit actions, document/procedural updates, MOC creation/execution, CAPAs
Define and implement automation and new capital projects to optimize QC Lab Operations. Ensures that required testing methods are in place for all testing required for Tissue and Biologics
Prepares reports and presentations by collecting, analyzing, and summarizing data, making recommendations
Provide statistical data support for various Lean projects within QC. Develop any Project Charters required for Lab Improvement/cost savings projects
Lead Quality Control issue resolution by applying root cause methodologies
Participate in FDA inspections and internal audits
Deploying proactive quality controls for consistent and predictable quality outcomes
Establish and track metrics for monitoring laboratory effectiveness
Report to management on quality issues and investigations
Provide functional support as needed for all team members
Qualification
Required
Bachelor's degree in chemistry/biology, or closely related field
5+ years' experience in Quality Control laboratory, R&D Laboratory, or Quality Engineering preferably in a Biologics or Pharmaceutical related field
Understanding of quality control instrumentation, troubleshooting, and testing methods including data integrity and qualification requirements
Problem solving using root cause methodologies including lean principles
Applying statistics and software in data analysis (example Minitab)
Quality system regulations and requirements (examples 21 CFR part 600, 21 CFR Part 1271, 21 CFR Part 210/211)
Preferred
Six Sigma Green/Black Belt preferred
Specific experience with ELISA based assays and software preferred
Benefits
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
Health, Dental, Vision
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
Disability Insurance
Company
axogen
AxoGen is a biotech company developing treatment options for the reconstruction and repair of peripheral nerve injuries.
201-500 employees
H1B Sponsorship
axogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$131.92MKey Investors
PDL Biopharma
2017-11-15Post Ipo Equity· $41M
2015-08-28Post Ipo Equity· $17.5M
2015-02-05Post Ipo Equity· $13M
Leadership Team
Michael Dale
President and Chief Executive Officer
Nir Naor
Chief Financial Officer
Recent News
2025-12-05
2025-12-05
2025-12-04
Company data provided by crunchbase