Senior Associate Scientist/Scientist, Analytical Development
Who We Are
Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!
DNS has an opportunity for an experienced candidate to perform analytical activities in support of DNS’ small molecule drug substances (NCEs) and drug products in clinical development. This position will work closely with external contract manufacturing and testing organizations and with internal Process Chemistry and Formulation Development functions. The specific skills and responsibilities include:
• Perform analytical activities for small molecule drug substances and drug products according to regulatory requirements for investigational products.
• Develop and transfer in-house developed analytical methods to external contract organizations.
• Manage analytical activities at external contract organizations and provide support during the manufacturing campaigns for drug substances and drug products
• Provide analytical support for internal Process Chemistry and Formulation functions.
• Maintain proper documentation of laboratory experiments.
• Author internal analytical reports in support of regulatory filings and review analytical documents and data generated by external contract organizations.
• Participate in technical visits and audits to external contract organizations.
• M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, or related fields with a minimum 3 years of hands-on experience in performing analytical development and testing activities in the pharmaceutical industry.
• Experience with analytical method development and validation for small molecule drug substances (NCEs) and drug products is a must.
• Strong proficiency with UPLC, HPLC, GC, Dissolution, and solid state characterization (e.g. DSC, TGA, XRPD) instrumentation.
• Knowledge of the CMC regulatory requirements (e.g. FDA, EMEA, and ICH) and thorough understanding of working in a cGMP environment is highly desirable.
• Excellent oral and written communication skills.
• Strong technical, project management, and interpersonal skills.
• Ability to work independently using critical and creative thinking skills to solve problems and advance the development objectives of the company.
• May require up to 15% travelling.
DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.
Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.