In this role, you will develop robust analytical methods for products under development and provide continuous support from feasibility to scale up of the products in order to facilitate timely ANDA submissions.
In this role, you will evaluate, test, and qualify new raw materials for cost-savings and process improvements. Where appropriate, develop processes to produce intermediates which replace raw materials.
In this role, the selected candidate will act as an analytical resource across the areas of method development, validation, transfer and formulation support, mostly utilizing HPLC and possibly UPLC and GC; will focus on the testing of small molecule Generic drug products.
In this role, the selected candidate will prepare analytical chemistry documents for submission to FDA that include, but not limited to, specifications, procedures, method validation reports, protocols, and certificate of analyses.
In this role, you will perform advanced analyses, tests, and development of new or updated formulas that require specialized understanding of chemistry, product lines, and materials; determines quality standards.
The main purpose of the role is to research and develop , new products to clients requirements and ensure all elements of design, formulation and manufacturing are safe , and accurate - taking into consideration any 3rd party manufacturing products.
In this role, you will independently sets-up, maintains, operates and performs routine and non-routine maintenance on laboratory equipment and software, including problem identification and resolution.
The selected candidate will be responsible for meticulous self-starter who understands and respects strict GLP Laboratory regulations and works within established guidelines, innovative professional who knows how to improvise and improve formulations while protecting company IP using thorough documentation procedures.
The Senior Analytical Chemist will provide technical guidance, solve problems, and make a hands-on contribution from R&D method development through GLP/GMP method validation and transfer in a fast-paced CRO/CMO environment.
The candidates will be working as part of the Analytical department that also performs the analysis of samples using a range of modern analytical techniques to investigate their chemical and physical properties.
In this role, you will work with process engineering and manufacturing to resolve production issues and achieve product attributes. Communicate with TPMs, Product Development, and Marketing to clearly understand timing, objectives, and development constraints.
In this role, you will participate in analytical activities related to raw material assessment, new product development, method development and validation and performs assigned analytical activates to support on-going projects.