Process Development Manager
Oregon Freeze Dry is a world class, purpose-driven technology solutions company with nearly six decades of freeze-drying expertise. We find inspiration in our ability to create solutions that improve the lives of individuals and communities around the globe. Our customers and consumers look to us to do this through the science and craft of freeze-drying / lyophilization. Our driven and passionate team needs to expand as we continue to experience strong sustainable growth across multiple markets.
We are looking for the intellectually curious who want to make a difference in a fast growing, quick paced team environment and who are inspired by the opportunity to pioneer new areas that touch lives all over the world! Are you that person?
We are seeking a Manager of Bio|Pharma Process Development. We bring an innovative approach to designing and commercializing new product concepts, whether for start-up or Fortune 100 multinational organizations. This position will manage the team responsible for the design and execution of pilot and plant level process development from prototype to commercialization, including cycle development, validation batches, and commercial batches. This role will also lead improvement projects associated with company strategic goals.
SPECIFIC DUTIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
- Leads Bio|Pharma Development by providing expertise in experimental design for process development, data analysis, and recommending data driven results. Effectively scales up new projects from benchtop through pilot, clinical, and commercial batches using appropriate experimental design, data analysis methods, and compliant documentation. Responsible for accurate, timely completion of commercialization projects (plant scale ups). Assists teams, Quality Assurance, and Chief Compliance Officer (CCO), or representative, in development of appropriate analytical method development. Manages teams to support chamber and plant operations through cycle analysis, deviation review, and participate in root cause/fish bone analysis along with operator log data maintenance. Responsible for overseeing status for accurate, timely, completion of projects and communication with leadership. Provides technical direction and support on plant process development and to commercialization teams leadership. Manages technical activities supporting Manufacturing and Engineering in equipment design and optimization.
- Establishes and sustains effective relationships within team in order to foster an environment where innovation, continuous improvement, and cooperation are used to solve problems.
- Leads teams to maintain OFD’s leadership in the area of lyophilization technology and alternative preservation technology. Assists in continuous improvement of LyoLock as recognized process system platform for internal process and marketing activities.
- Bachelor in Engineering or Science degree or closely related field. Equivalent work experience will be considered in lieu of degree.
- Minimum of 5 years’ experience in related field.
- Knowledge of lyophilization and or other preservation technologies with an understanding how this translates to defining critical drying parameters for retaining critical properties.
- Understanding of statistical analysis methods and applications.
- General knowledge of Lean Six Sigma concepts.
- Demonstrated good verbal and written communication skills through positive and effective information sharing.
- Demonstrated independent ability to analyze data, draw conclusions, and present results.
- Demonstrated experience working with cross-functional teams on projects impacting multiple departments.
- Excellent written and verbal communication skills.
- Corporate level proficiency in MS Word, Excel, PowerPoint, and computer skills.
SALARY AND BENEFITS:
- Competitive salary and benefits package including medical, dental, vision, paid time off, paid holidays, and more!