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Group Leader, AR & D at Amneal Pharmceuticals LLC in Piscataway, New Jersey

Posted in Science 30+ days ago.

Type: Full-Time





Job Description:

Description:


  • 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.

Essential Functions:


  • 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.

Education:


  • 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

Experience:


  • in See above