Biotech Production Specialist - Fill Finish

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:

• Assists and/or contributes in all areas of production as needed.

• Includes all aspects of biotech production activities related to cell culture.

• Monitors production processes including cell culture and purification activities for drug substance manufacturing and filling, and inspection and packaging activities for drug product manufacturing.

• 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 and cleaning of equipment.       

• Participates in equipment start-up, commissioning and validation activities.

• Ensures equipment operational readiness.

• Assists 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.

• Assists 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.

• Provides input to production activities scheduling.

• Coordinates regular equipment maintenance and calibrations.

• Must be able to push, pull and lift 50 lbs.

Education and Experience:

• Requires BS/BA in Life Sciences or related field or AS/AAS in Biotechnology/Biological Science or equivalent combination of education and experience.
   

Level is determined based on relevance to the role.