The Scientist III, AR & D is responsible for the development and characterization of transdermal drug delivery systems- matrix, hydrogel and oral-thin film. Activities include formulation development and characterization work including material selection and procurement, mixing, drying, pilot scale-up, and Exhibit Batch manufacturing. The individual is responsible for the development and identification of lead generic and 505b2 transdermal formulations. Develop various transdermal formulations and evaluate the critical chemical and physical properties of the formulations and corresponding raw materials. Advance numerous programs in collaboration with Senior Scientists and Analytical chemists. Characterize physical properties, skin flux, and critical raw materials attributes that ensure robust manufacture and product performance. Responsible for successful formulation development and development of batch records for clinical supply manufacture. Compile ANDA modules for FDA review, and provide timely responses to inquiries to ensure that project objectives and goals are met. Proven track record in Transdermal Product development, demonstrating hands-on experience in a variety of the field's concepts, practices and procedures. Knowledge of drug-in-adhesive matrix formulation development, especially formulating to achieve the drug delivery target while maintaining acceptable adhesive rheology for acceptable wear, cold flow, and product manufacturing. High mechanical aptitude with some travel between facilities required.
Develops and optimizes new and existing analytical methods for qualification and release testing of the products. Develops stability indicating product testing methods and performs method validation, complying with all applicable regulations, guidelines and internal SOPs.
Expands analytical capabilities of the department. Provides training and guidance to Analytical Group members with developing technical skills.
Provides timely responses to internal and external inquiries related to pharmaceutical testing and quality.
Prepares scientific or technical reports or presentations for analytical development and analysis.
Additional responsibilities includes staying abreast of new development in analytical techniques such as High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Fourier Transform Infrared Spectroscopy (FT-IR), Ultraviolet-visible (UV-Vis) spectrometers, Karl-Fischer titrator (KF titrator) and Dissolution apparatus. Contributes to improvement in laboratory operations to increase efficiency.
A Bachelors Degree (BA/BS) in Chemistry or related science is required.
A Master Degree (MS/MA) in Chemistry or related science is preferred.
5 years or more with pharmaceutical experience (with Bachelor's Degree) is required.
3 years or more with pharmaceutical experience (Master's Degree) is required.
Enthusiasm and dedication performing as an individual contributor and in a team environment. - Intermediate
Written and verbal communication and presentation skills. - Intermediate
Ability to set priorities and to follow through on commitments utilizing organizational skills. - Intermediate
Microsoft Office and ability to learn additional software/programs as needed. - Intermediate
Ability to lead projects, and meet deadlines. - Intermediate
Creativity to solve technical and compliance problems. - Intermediate
Knowledge of modern analytical instrument/equipment and techniques. Experience with High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Visible Spectrophotometer (UV-Spectrophotometer), Fourier Transform Infrared Spectroscopy (FT-IR), Dissolution apparatus and general laboratory equipment/instrument. Method development and validation knowledge or experience.