method transfers. Lead root cause investigation and failure analysis using structured problem-solving methodologies (8D.... Proven experience designing and executing validation protocols (process, method, equipment, CSV/computer systems...
, and related products. This role collaborates closely with a Formulations Chemist to develop, refine, and evaluate new and existing... formulations, while also providing backup support for research and quality control testing of raw materials and finished products...
Practice (GMP) manufacturing by performing analytical testing for commercial products and stability studies in a cGMP... required testing qualifications on each method before progressing to additional assays. Essential Skills At least 1 year of proven...
, in vitro, and in vivo tests to ensure that raw materials, in-process samples, and finished products meet stringent quality... Procedures (SOPs) to perform testing on raw materials, in-process samples, and finished products, ensuring they meet established...
. Assist in planning, executing, and documenting Test Method Validation (TMV) activities to ensure methods are suitable... and commercialization of products. Work closely with Manufacturing, Quality, and Engineering teams to execute validation and improvement...
Practice (GMP) manufacturing by performing analytical testing for commercial products and stability studies in a cGMP... required testing qualifications on each method before progressing to additional assays. Essential Skills At least 1 year of proven...
products is a strong plus. Familiarity with hazardous waste handling and disposal requirements. Experience supporting method..., collaborative team to perform HPLC and other solid dosage testing on nutraceutical products, lead or support finished product...
are responsible for designing, developing, testing and maintaining software applications and products to meet customer needs... or service and determine the most suitable technology stack, integration method, deployment strategy, etc. Create high-level...
with internal operations and external manufacturing partners. This role is responsible for ensuring clinical and commercial products... with analytical and technical teams to perform GMP reviews of stability studies, analytical testing, method validations, and method...
supports the manufacture of AAV viral vector drug products by performing complex analytical and bioanalytical testing... across the product lifecycle. This role focuses on testing starting materials, in-process and finished drug products...