Associate Scientist, Analytical Development/Formulations - San Diego, CA | Biospace
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Associate Scientist, Analytical Development/Formulations

Dart NeuroScience LLC

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Location:
San Diego, CA
Posted Date:
5/8/2017
Position Type:
Full time
Job Code:
17-030 #802836
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Analytical Chemistry, Chemistry, Formulation, Pharmaceutical,

Job Description

Perform analytical activities in support of DNS’ small molecule drug substances (NCEs) and drug products in clinical development. Work closely with external contract manufacturing and testing organizations and with internal Process Chemistry and Formulation Development functions.

• Perform analytical activities for small molecule drug substances and drug products according to regulatory requirements for investigational products.
• Under management supervision, develop and transfer in-house developed analytical methods to external contract organizations.
• Monitor data generated at external contract organizations and provide on-site support during critical testing activities 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.

Requirements

• BS or MS in Chemistry, Pharmaceutical Sciences 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, and Dissolution 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.