Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
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.
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 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 Sr. Scientist, Quality Control
The Quality Control Sr. Scientist provides test method and qualification support along with implementation of new processes, instrumentation, cost savings, and continuous improvements. The position will support the required action steps and process improvements to meet Biologics requirements. Position will ensure QC lab complies with applicable standards and regulations and partner with various APC and/or corporate departments to complete required testing and documentation.
Requirements of the Sr. Scientist, Quality Control
- 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.
- Six Sigma Green/Black Belt preferred
- Understanding of quality control instrumentation, troubleshooting, and testing methods including data integrity and qualification requirements.
- Experience leading 5S and stability programs for the lab
- Leadership skills to support the analytical team (encompassing ELISA, pH, osmolality, KF, UV assay, eventually LC)
- 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)
Responsibilities of the Sr. Scientist, Quality Control
The specific duties of the Sr. Scientist, Quality Control include but are not limited to:
- 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.
Location
913 Industrial Drive Place, 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.
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
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What We Do
Axogen is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or discontinuity to peripheral nerves by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers.
Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.
Axogen’s comprehensive portfolio of products focuses on helping patients touch, run, feel, kiss, smile and hug—some of the many things healthy peripheral nerves allow us to do.
