Summary: Under limited direction and supervision, carries out design and development of solid oral dosage forms through ANDA filing and/or product launch. Develops and executes formulation strategies related to product development, e.g. project planning and timelines, experimental design, data evaluation, formulation of relevant and scientifically based conclusions, coordinates studies with other technical groups (Analytical Sciences, Legal, and Regulatory & Pharma Tech). Maintains a high level of expertise within the field and develops new technologies and concepts to be applied in the development of oral controlled release drug products. Identifies, analyzes and suggests corrective actions to optimize R&D processes, technology and regulatory compliance issues.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
* Carries out responsibilities in accordance with the organization?s policies, procedures, and state, federal and local laws.
* Designs experimental plan; performs pre-formulation, formulation development work on Oral Controlled release and immediate release dosage forms. Generates and reviews analytical data to support the product development work.
* Writes protocols and batch records to carry out process development and evaluation work, scale up and pivotal batch manufacturing for Abbreviated New Drug Applications (ANDA?s) submission to regulatory agency. Plans appropriate analytical testing and stability studies on pivotal batches.
* Performs appropriate documention and prepares pharmaceutical product development report (PDR) ,Quality overall Summary (QOS) and other necessary documents to support regulatory filing of ANDA?s.
* Surveys the scientific literature and performs patent search to remain current with recent developments in generic pharmaceutical research and regulatory arena and novel drug delivery systems.
* Plans bioequivalence studies on drug product and evaluates the bioequivalence data to recommend changes in formulation, if needed.
* Maintains appropriate documentation of primary data records, report sheets and laboratory notebooks as required by Standard Operating Procedures.
* Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Ensures compliance with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), all Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulations and guidelines.
* Provides scientific and technical directions to junior staff members (Scientists, Technicians & Operators) to ensure project deadlines and performance standards are met. Collaborates with supervisor to set priorities and reach objectives.
* Performs related duties as assigned.
- Advanced knowledge of theories, practices and principles of physical pharmacy, pharmaceutics, pharmacokinetics, biopharmaceutics and statistical designs.
- Product formulations, product stability, packaging, and FDA submission methods and practices.
- Product design of controlled release dosage forms, working knowledge of multiparticulate systems, matrix systems, diffusion controlled and osmotically engineered pharmaceutical dosage forms.
- Business, scientific and personal computer hardware and software applications.
- Business English usage, spelling, grammar and punctuation.
- Leadership and training practices and methods.
- Current Company policies, practices and procedures, including safety rules and regulations.
- Ability to efficiently handle pharmaceutical unit operations, such as fluid bed coater, compression, roller compaction, high shear granulation, particle and tablet coating, encapsulation and packaging.
- Leading the activities of technical personnel; making decisions and satisfying the needs of a research program.
- Communicating clearly and concisely, both orally and in writing.
- Operating scientific and personal computers.
- Managing multiple projects, duties and assignments.
- Coordinating and reviewing the work of assigned department personnel.
- Establishing and maintaining cooperative working relationships with others.
- Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
Minimum Qualifications: Bachelor?s Degree in Science or related scientific field from an accredited university, and eight (8) years related pharmaceutical experience or an equivalent combination of education and experience.