Annie Ewing
MORRISON, CO, United States, 80465,CO
Summary
Innovative and dynamic Director of Research and Development with 15+ years of experience in product development, process improvement, and laboratory management. Masterful in project management, aseptic technique, and good laboratory practices, ensuring seamless integration of research initiatives. Creative problem-solver and analytical thinker, adept at finding solutions and applying logical analysis to complex challenges.
Overview
20
20
years of professional experience
Work History
Director of Research and Development
Colorado Serum Company
07.2007 - Current
- Led team of 5 researchers in development and optimization of multiple vaccines for infectious diseases by coordinating research efforts and overseeing experimental design, resulting in advanced data and information
- Initiated implementation of GMP and GLP standards across research department and company-wide.
- Used and analytics tools to troubleshoot and resolve challenges during product development by analyzing data patterns, resulting in smoother development process and enhanced product quality
- Developed and implemented study design protocols, technical protocols, and study reports for multiple research projects, ensuring compliance with industry standards and regulations.
- Demonstrated expertise in navigating regulatory requirements and preparing comprehensive submissions to industrial regulating bodies for testing and product approval.
- Proficient in maintaining up-to-date knowledge of industrial regulations and proactively adapting compliance strategies to meet evolving standards
- Spearheads strategic planning and execution of design, development, and implementation of projects to ensure alignment with organizational goals and objectives.
- Pioneered novel testing methods and assay development and validation.
- Facilitated constant communication between upper management and scientific teams through regular progress updates, leading meetings to discuss project milestones and challenges.
- Utilized data-driven insights and performance metrics to pinpoint areas for optimization and proposed actionable improvement plans.
- In-depth working knowledge of upstream and downstream processing and bench-scale to scale-up design.
- Adept at bioreactor growth optimization of bacterial and mammalian cells, in vivo and in vitro assay development and validation, and protein purification.
- Mentored and supported scientific teams in conducting ongoing studies, testing methodologies, and data analysis techniques, resulting in increased efficiency and accuracy of results.
- Provides one-on-one mentoring and coaching to team individuals to promote professional growth and career development.
Veterinary Technician
VCA Ft. Collins Animal Hospital
05.2004 - 06.2007
Education
Bachelor of Science - Microbiology
Colorado State University
Ft. Collins, CO05.2005
Bachelor of Science - Biology and Zoology
Colorado State University
Ft. Collins, CO05.2004
Skills
- Project development and management
- Process Improvement
- Good manufacturing Practices (GMP), certified
- Good Laboratory Practices (GLP), certified
- Good documentation Practice (GdocP), certified
- Understanding of and adherence to regulatory guidance, and experienced with regulatory submission for approval and licensure
- Writing and implementing Standard Operating Procedures, Study Protocols and Outlines of Production
- Upstream and downstream production and processing
- Bench scale and scale-up product development
- In vitro and In vivo assay development and validation testing
- Bacterial and mammalian cell growth including CHO cells
- Protein isolation and purification
- Small and large scale bioreactor use
- Organized, creative and adaptable
- Intrapersonal communication, written and verbal
- CAPA plan development, problem solving, and brainstorming, certified
- Staff management, training, and mentoring
Timeline
Director of Research and Development
Colorado Serum Company
07.2007 - Current
Veterinary Technician
VCA Ft. Collins Animal Hospital
05.2004 - 06.2007
Bachelor of Science - Microbiology
Colorado State University
Bachelor of Science - Biology and Zoology
Colorado State University
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