The individual is responsible for performing and leading methods development, chemical and physical assays in support of pharmaceutical development projects. The individual will support the requirements of the stability program, method validation and process development program. The scientist will also perform project management or share with the Product Development Scientist the responsibilities of project management.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Include the following. Other duties may be assigned.
Provide technical support to department where required to ascertain degradation profiles, solve complex scientific problems and develop sophisticated analytical methods.
Develop analytical methods for drug substances, preservatives and degradation/impurities in the finished product. Validate new analytical methods in accordance to Akorn, Inc. procedures and FDA regulations. Maintain Lab equipment and keep all the records up-to date.
Mentor junior level scientists by providing technical guidance and train them in troubleshooting, enhancing their technical skills, etc.
Provide technical leadership for the analytical development. Assist R&D Supervisor in the laboratory management. Perform testing of samples as required to support product development, regulatory submissions and the stability program. Design and perform laboratory work to support product or process troubleshooting, special investigations and product complaints with minimal supervision. Assist in the general operation of the Research & Development analytical laboratory, including maintenance of Standard Operating Procedures (SOP’s), training and equipment validation or maintenance.
Support the team with the technical expertise in problem solving and by providing proper scientific rationale for studies designed in response to queries from agency. Characterization, identification of unknown impurities and their source in the finished product samples as necessary.
Support the department by actively participating in investigations and generating CAPAs as necessary. Assist the site management by overseeing the validation of new equipment and the maintenance of the existing analytical equipment. The individual will participate in the writing of stability reports, product development reports and product specifications. Maintain accurate and complete laboratory records as required by company policy and Good Manufacturing Practices (cGMP) and Good Document Practices (cGDP) requirements.
Assist formulation or other analytical scientists in the testing or preparation of drug products and samples. Set and accomplish product development timelines working closely with formulation scientist. Perform other duties as deemed necessary by the department management.
Design, develop, conduct and provide preliminary interpretation of study results with high level of independence.
Preference will be given to the individuals that have expertise in method development, analysis and interpretation of the Mass Spectrometry with hands on experience in LCMS, GCMS, ICPMS operation.
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