Pharmaceutical Development Technician
The Pharmaceutical Development Technician assist in manufacturing of sterile biologic products for clinical supply operations. Role will be focused on formulation of drug substance and includes preparation of production room, equipment and supplies for operation, process cleaning, and assisting in formulation of final drug form before filling. Other responsibilities include preparation of equipment and components and sterilization, upkeep and cleaning of production area and inventory management.
- Assist in the manufacture of pharmaceutical parenteral products for use in clinical studies. Operations are carried out in a cGMP compliant manner with strict adherence to OSHA safety requirements, SOP's and batch records.
- Unit operations include but are not limited to parts washing, parts preparation & sterilization, buffer preparation, active formulation, integrity testing of equipment & product filters, visual inspection and general maintenance and cleaning of the manufacturing area.
- Responsible for equipment setup and operation, batch execution including completion of associated batch documentation and equipment logs, equipment cleaning and equipment storage.
- Entry of data into computer terminals when required.
- Position may include handling of potent compounds.
- Perform in accordance with specific instructions, all operations necessary for the operation and cleaning of equipment used for the above mentioned operations.
- Alert supervisor of any irregularities in procedures or equipment operation.
- Perform preventative maintenance as required.
- Adheres to the established manufacturing schedule for all assigned batches from start to completion
- A two year Associate Degree in Science related to Pharmaceutical Development or equivalent field. In lieu of a two-year degree, a minimum of four years' working experience GMP pharmaceutical manufacturing or related field.
- Proficiency in the use of computer programs/systems is essential.