The purpose of this position is in the execution and timely completion of formulation development of pharmaceutical Transdermal Drug Delivery Systems (TD Patches) and Oral fast dissolving film dosage form as per QBD guidelines. This position is responsible for formulation development activities of projects within stipulated agreed timelines.
Familiar with ANDA filing CMC related activities including formulation development, process development and container/closure system.
Support GLP/GMP manufacturing including provision of process instruction, batch record review and hands on transdermal process development.
The position will involve developing and executing technical plans to meet target drug product profiles through in house research Produce deliverables for assigned projects in a timely manner
Other duties as required
Bachelor's of Science OR Master's of Science in Pharmaceutical sciences with at least 5 years of experience.
Experience in Transdermal Product development and/or Fast Dissolving Oral film System in GMP laboratory setting.
Experience with in vitro release testing methods for oral film product and transdermal product (IVRT & IVSP).
Strong Interpersonal, communication and problem solving skills
Our Company is committed to a policy of equal employment opportunity. It is the Company’s policy to administer all human resources actions and policies without regard to race, age, color, religion, sex, marital status, nationality, national origin, ancestry, mental or physical disability, affectional or sexual orientation, genetic information, atypical hereditary cellular or blood trait, citizenship status, any veteran status or any military service or application for any military service, or any other class protected by law. All employment decisions and personal actions, including, without limitation, recruiting, hiring, placement, promotion, compensation, benefits, transfers, terminations, layoffs, training, education and social and recreational programs, are and will continue to be administered in accordance with and to further the principle of equal employment opportunity. Performance of supervisors and employees alike will be evaluated on the bias of the equal opportunity efforts as well as other criteria.
About Aurobindo Pharma USA
Aurobindo has built a new 40,000 sq. ft. state-of-the-art R&D and pilot plant facility in Durham, North Carolina. Further, build-out of a cGMP manufacturing facility for commercialization of specialty products on the same site has been completed. The new R&D labs site will house over 50 scientists, including highly experienced pMDI aerosol, topical and transdermal R&D teams, with associated analytical and testing labs.