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:
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.
Provide technical leadership for the analytical development. Assist R&D Supervisor in the laboratory management. Develop and validate stability indicating assay procedures for pharmaceutical chemicals and finished dosage forms.
Perform testing of samples as required to support product development, regulatory submissions and the commercial stability program. Perform laboratory work to support product or process troubleshooting, special investigations and product complaints with sufficient 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.
Perform laboratory work to support method validation or investigations. Assist performing 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) 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.
BS/MS/PhD in the chemical, pharmaceutical or life sciences required
A minimum of 4 years related experience and/or training; or equivalent combination of education and experience.
Requires superior writing skills. Requires exceptional attention to detail with the ability to focus on current assignments. While Laboratory mistakes are unavoidable they must be kept to a minimum due to their ramifications.
Requires initiative and self-motivation works with moderate supervision in a detail-oriented manner. Requires the ability to work on multiple projects in a concurrent manner.
Must possess the ability to work in an independent manner, as well as a group environment.
Satisfactory completes initial and annual training for cGMP and corporate operating procedures.
The individual must have demonstrated thorough working knowledge of chemical analysis, including HPLC. The position requires good verbal and written communication skills and the ability to comprehend complex instructions and tasks. The individual must also have a fundamental understanding of algebra and statistics.