Date PostedApril 25, 2023
Experience10 Years, 17 Years
Desired QualificationDoctorate Degree
Roles and Responsibilities:
- Responsible for leading the research and development of new drug formulations for parenteral administration (administration through injection or infusion) and for overseeing the development of existing formulations.
- This includes designing and conducting laboratory experiments, analyzing data, and interpreting results.
- They also contribute to the development of regulatory filings and provide technical support for manufacturing operations.
- Responsible for leading the team of scientists and technicians working on the formulation and development of parenterals.
- They also work closely with other departments such as regulatory affairs, clinical development, etc, to ensure that projects are completed on time and to the appropriate quality standards.
Desired Candidate profile
- A Ph.D. or equivalent degree in a relevant scientific field such as pharmacy, chemistry, or biotechnology.
- A minimum of 10-15 years of experience in the pharmaceutical industry, with experience in parenteral formulation and development.(Pref-Complex Generics)
- Strong understanding of pharmaceutical development processes, including pre-formulation studies, formulation development, process development, and technology transfer.
- Knowledge of regulatory requirements for parenteral drug development and experience with regulatory filings.
- Strong analytical and problem-solving skills, as well as a demonstrated ability to design, execute, and interpret laboratory experiments.
- Excellent communication and leadership skills, with the ability to lead a team of scientists and technicians.
- Strong organizational skills and the ability to manage multiple projects simultaneously.
- Familiarity with relevant industry standards and best practices for parenteral formulation and development.
- Experience with the development of complex generic parenteral formulations, including those that are difficult to formulate or have specific requirements such as controlled release or targeted delivery.
- Experience with the development of new drug applications (NDAs) for parenteral products, including the preparation of regulatory filings and interactions with regulatory agencies.
- Knowledge of the specific regulatory requirements for complex generics and new drug applications, including the demonstration of bioequivalence and the need for clinical data.
- Experience with the development of analytical methods for complex parenteral formulations, including methods for characterizing controlled release formulations and targeted delivery systems.
- Experience with the scale-up and manufacturing of complex parenteral formulations, including the optimization of process parameters and the resolution of any manufacturing-related issues that may arise.