Manufacturing Associate IV (Drug Product)

In this role you will be responsible for performing and documenting daily manufacturing operations in a cGMP environment. This involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments. Applicants will be highly detailed oriented with excellent documentation skills. Applicants will become trained and skilled at most or all unit operations in their area, often leading the execution of procedures, and performs most functions with minimal supervision.

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and control system. May coordinate or lead process steps as requested
• Documents/Records and Reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Revises or creates documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks.
• Actively participates in training activities, managing their individual training plan. Trains other associates as required.
• Executes validation protocols with minimal supervision/direction of others.

*LI-POT7

We are interested in hearing from candidates with a proven track record of success in the following areas:

• Targeted biopharmaceutical training (Bio-works or equivalent) and/or related military training also preferred
• Detailed oriented with excellent

In this role you will be responsible for performing and documenting daily manufacturing operations in a cGMP environment.