SUMMARY OF POSITION
The Associate Director of Product Development (R&D) leads the development of ANDAs and 505(b)(2) NDAs that meets the expected FDA standards which can be successfully filed with USFDA. The primary focus will be on the development of Injectables, specifically long acting injectables.
This US-based role reports to the Sr. Vice President, US Research and Development and is based in Pine Brook, NJ. Direct reports to this position may include Scientists and Formulation Managers in the future.
Primary responsibilities of this role include the following:
• Leading, managing and setting the direction for formulation of injectable dosage forms that are solutions, suspensions, lyophilized, liposomal or long acting. • Conduct initial project evaluation for new projects and propose formulation and process development strategies • Guide the development of formulation and process from laboratory scale to registration • Provide formulation and process expertise to troubleshoot issues with approved and existing products • Provide responses to FDA deficiency letters (IR, DRL or CRL) to obtain timely approval of products pending with the agency • Author, review and approve FDA submission documents such as original pre-IND and IND submissions, amendments, product development reports, quality overall summary and other relevant sections for filing • Serve as a department liaison in cross-functional teams including analytical development, regulatory, quality and operations • Serve on the portfolio team to provide technical assessment for new product selection • Prepare and manage department budget • Manage CMO’s for third-party projects
• Ph.D. with 8 years of experience or M.S. with 12+ years of experience in the pharmaceutical industry • 3-5 years of Injectable product development experience with focus on long acting injectables • Proven track record of filing ANDAs/NDAs • Knowledge of first to file and paragraph IV filings • Strong knowledge in pre-formulation, formulation development and process development from early stage to registration scale • Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems. • Refined written and verbal communications and presentation skills • Strong organizational skills • Ability to manage and drive assigned projects to an on time deliver • Experience in leading and managing personnel in a pharmaceutical laboratory setting
GMP DECISION-MAKING AUTHORITY
• The Associate Director has the authority to manage future team members though all aspects of development in the department. This includes the authority to manage personnel performance and make employment hiring, salary and retention recommendations. • Review and approve GMP documents as required • Provides technical input for any GMP batches being manufactured on-site and at CMO
We are an EEO Employer.