A leader in the biotech industry with a patient-focused and research & development-led approach is currently seeking a Director of Analytical Development in the Raleigh, North Carolina area. They have experienced strong long-term growth and recent success and are looking to add more key contributors to collaborate with the team. The individual will closely collaborate with cross-functional Analytical Development and CMC team members. The individual should be proactive in identifying potential issues, develop effective solutions to technical challenges, and lead team members in the execution of analytical development.
Responsibilities:
- Provide technical leadership in execution of analytical development, as well as process development/engineering and clinical drug product manufacturing support
- Author and review development documents and support regulatory responses
- Represent drug product development within cross functional project teams, organizational initiatives, and technology development groups
- Identify, evaluate, and develop formulation and drug product technologies to continuously improve business processes and product development capabilities
- Design and execute DP formulation development, process development, process characterization, and process validation studies
Requirements:
- Masters degree in chemistry, biology, engineering, or related pharmaceutical science field and 10+ years of related experience, OR:
- D. in chemistry, biology, engineering or related pharmaceutical science field and 5 years of industry related experience preferred
- Extensive knowledge of CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP
- Prior experience with the use of contract facilities
- 8+ years of experience working with extractables and leachables preffered
- Successful experience in working in a multi-disciplinary team environment
This is a unique opportunity to grow your career with a company dedicated to its employees and its patients. If you are interested in the Director of Analytical Development role, apply today.
