The Senior Analytical Scientist will develop analytical methods for quality control and characterization of products, lead drug product development programs and provide analytical and technical support for process development and manufacturing. Responsibilities include developing appropriate quality measures for Summit Biosciences' products, developing, validating, transferring or verifying analytical methods, characterizing products and processes, training and creation of documentation.
location: Lexington, Kentucky
job type: Permanent
salary: $90,000 - 100,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
- Lead scientific aspects of nasal spray drug product development projects
- Provide expertise in chemistry and analytics related to Summits' products
- Responsible for the design and conduct of analytical development in accordance with company and regulatory standards to facilitate new product development
- Responsible for multi-department and multi-site communications required to facilitate new product development
- Manage technical direction of projects by identifying key deliverables, next steps and communicating with teams
- Prioritizes workload to ensure that key objectives are met on time and to budget
- Lead method development and product characterization for multiple projects
- Conducts technical projects with the appropriate use of company resources in mind
- Make recommendations for continuous improvement projects that improve effectiveness
- Author and review technical reports, regulatory submissions, SOPs, validation protocols and other cGMP documents
- Identify and implement new techniques and instrumentation to expand internal capabilities
- Assist junior staff to apply complex fundamental knowledge, laboratory procedures, or testing apparatus/ methods
- Knowledge, Skills and Abilities:
- Extensive technical experience in analysis and development of pharmaceuticals
- Comprehensive understanding of small molecule and large molecule chemistry
- Demonstrated knowledge of modern analytical techniques, including HPLC.
- Knowledge of nasal spray characterization a plus.
- Expertise in Pharmaceutical aspects of Leachables and Extractables
- Experience in development and validation of methods destined for QC in the pharmaceutical industry
- Understanding of current Good Manufacturing Practices (cGMPs)
- Proven team player with well-developed interpersonal and mentoring skills, excellent organizational skills, communication skills, including written documentation skills and presentation skills
qualifications:
- Degree in Chemistry, Pharmaceutics or related field; advanced degree is a plus
- Extensive experience in analytical and drug product development activities regulated by FDA
- Outstanding capabilities for adjusting priorities in response to changing conditions and schedules
- Experience with nasal spray drug product development and characterization is a plus
skills: Analytical Chemistry
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
