Formulation Associate

The Formulation Associate will perform all formulation operations in the area of assignment and support start-up/changeovers/tech transfer activities. This position works under the immediate direction of the Formulation Supervisor and all work is conducted following a high standard of GMP compliance and written SOP and batch records.

• Operate glass washers and autoclave, prepare buffers and medias and other solutions
• Operate process equipment such as tanks, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
• Daily completion of formulation activities ensuring all scheduled tasks/events are completed
• Formulation process steps including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss
• Initiate the production of batch used for engineering and cGMP production and initiate thawing of the API as required
• Execute Batch Records accurately and complete prior to submission for review
• Author process deviations when they occur within the department, participate in investigations and contribute to identifying corrective and preventative actions
• Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
• Conduct all work in compliance with FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance

The position requires up to 4 years of experience in a GMP environment performing and using formulation/compounding processes and equipment along with an Associate's or Bachelor's degree in a science-related discipline or equivalent GMP experience.