Responsible for providing technical and scientific leadership in developing formulations leading to successful ANDA filing and approval with limited direction and supervision. Demonstrates ability to work effectively in a multi disciplinary team under defined timelines in the area of preformulation, formulation and process development of immediate release and modified release solid dosage form. Direct supervision of 2 to 5 technical staff.
Handle 12-15 chemists. Optimize the performance, teamwork, and effectiveness of the group to ensure on-time release and stability study of ANDA exhibit batches for FDA submission.
Responsible to release in-process, finished product and stability of ANDA for Oral solution, Oral suspension, Topical cream, Gel ointment, Nasal Spray, Inhalation Solution and Transdermal System.
Responsible for performing the additional studies (e.g Temperature cycle, Photostability, In-use study, cap compatibility and drug compatibility with additional packaging components) for ANDA submission.
Ensure analysts are trained regarding the operations of equipment and performing new methods and/or analytical techniques as well as company policies.
Support the response to FDA queries
When needed, develop methods and perform lab work on a priority basis.
Communicate with Quality Assurance and Formulation on investigations of ANDA stability issues.
Adhere to all cGMPS compliance/regulatory mandates and quality requirements Ensure that good laboratory practices and established lab rules are followed in the laboratory.
Have complete understanding of and the ability to apply SOPs,GMPs,GLPs, department procedures and controlled substance handling procedures to complete the projects.
Bachelors Degree (BA/BS) Pharmaceutical Sciences or related field (4 to 6 yrs of experience) or - Required
Master Degree (MS/MA) Pharmaceutical Sciences or related field (with 2 to 4 years of experience) - Preferred