SUMMARY: 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.
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.
Qualifications EDUCATION AND EXPERIENCE: BS/MS/PhD in the chemical, pharmaceutical or life sciences with at least four years related experience and/or training; or equivalent combination of education and experience.
Company Overview Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
EEO Statement Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.