Associate Director, Technical Operations.
This position is a vital member of the Aziyo Biologics team and, as such, it is involved in executing the Company’s goals and objectives related to research and development. This position is responsible for driving the product development of ECM-based regenerative products and drug/device combination products while ensuring compliance with Aziyo’s quality and regulatory standards. The successful candidate will have the opportunities to lead technology and product development from the feasibility phase to product commercialization. This successful candidate may also lead the design, optimization, and qualification of a broad range of bioassays, analytical methods, mechanical methods, in vitro and in vivo test methods (in-house or through CROs) to support regulatory submissions and product launch. The successful candidate will be an independent critical thinker with exceptional problem-solving skills relating to the biotech industry and research.
The position reports to Director, Operations & Engineering.
Essential Duties & Responsibilities
- Lead or support the design and characterization of drug/device combination products in accordance with industry standards.
- Support prototype and pilot production of new products in coordination with Aziyo’s Manufacturing and Quality Control Systems.
- Capable of developing and executing test methods to aid in exploratory research and new techniques.
- Using critical thinking skills to find feasible solutions to technical issues in the lab as well as product development and design.
- Offer expert analysis and advice in/on but not limited to analytical chemistry, biomedical engineering, and polymer material science.
- Establish the testing plan, device limitations and acceptance criteria and ensure the timely completion of the technical deliverables.
- Maintain state-of-the art knowledge in scientific principles, theories and clinical practice in one or more of Aziyo’s strategic focus areas.
- Participate in development of patent applications.
- Maintain accurate and timely records of design and development activities in accordance with written procedures.
- Comply with Aziyo’s Quality systems.
- Lead project management teams.
- Collaborate with multiple functions, including Marketing, Regulatory Affairs, Quality and Clinical Operations.
- Present data to all levels of the Company, including senior management and peers.
Minimum Bachelor’s degree in general science or engineering (Biomedical Engineering, Chemical Engineering, Material Science, Chemistry, Life Sciences, or related field) from an accredited college or university or an equivalent combination of education and work experience. Advanced degree preferred.
Experience and Skills
Work Experience Required:
- Minimum 5 years’ experience within Medical device (especially combination device), Biotech or Biopharm.
- Preferred experience with drug-device combination product, controlled release, biomedical engineering or related engineering.
- Preferred experience with test method and analytical method development and validation.
- Preferred experience with Design Controls and FDA submissions.
Specialized Skills, Knowledge:
- Excellent written, communication, and presentation skills.
- Operate and maintain laboratory equipment.
- Contribute, follow, and modify chemical analysis and laboratory procedures.
- Critical thinking, time management, decision making, and problem-solving skills relating to polymer, biomaterials, and organic chemistry.
- Proficient knowledge of computer programs (word processing, spreadsheets, and presentations).
Must be able to stand for long periods of time.
Aziyo Biologics is an equal opportunity employer committed to affirmative action and diversity in our workforce.
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