Summary: Performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Includes all aspects of biotech production activities related to cell culture and purification.
* Assists/contributes in all areas of production as needed.
* Reviews, edits, completes, and revises completed batch records, Logbooks, and SOPs in accordance with cGMP standards and compliant with written procedure.
* Ensures availability of production batch records for upcoming lots.
* Performs manufacturing level maintenance on equipment.
* Monitors production processes.
* Participates in equipment start-up, commissioning, and validation activities.
* Ensures equipment operational readiness.
* Assist with troubleshooting in case of equipment failure.
* Gathers, trends, and analyzes process generated data.
* Participates in defining robust process parameters during routine manufacturing campaigns.
* Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns.
* Creates process evaluation reports, process transfer documentation, and process characterization presentations.
* Documents all training;
* Assist with training of new employees.
* Performs various tests and analytical procedures.
* Performs in-process sampling, Quality Control Chemistry and Quality Control Microbiology.
* Keeps process area stocked with essential equipment and components.
* Ensures all tasks are performed in a manner consistent with safety standards.
Education and Experience:
BS/BA in Life Sciences or related field preferred; will substitute relevant work experience in lieu of degree requirement. Experience in an SOP, ISO, or similar regulated environment strongly desired.