Performs professional, technical laboratory functions.

The Senior Manager of Process Development (PD) in Research and Development (R&D) will manage the R&D Development Engineers (DEs) and will be responsible for managing the strategy of R&D DE projects. The main scope of the Process Development Department will include process scale-up, materials purchasing coordination with procurement for scale-up activities, materials qualifications, manufacturing support, and process improvements. Other activities such as maintenance and inventory of controlled substances, product transfers, Design History File (DHF) support and cross functional activities with the Pharmaceutics team will occasionally occur. Some of the specific responsibilities for this position include reviewing protocols, reports, and...

Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations.  Document all work performed, ensuring accuracy and thoroughness.  Inform management of any deviations from established standards/procedures.

Provide technical support to manufacturing, engineering and other departments / teams by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components. 

Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment.  Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities.  Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.

Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment.  Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities.  Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.

Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment.  Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities.  Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.

The Mfg Operator BC performs all the general duties and operations to manufacture the product. An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. The operator will complete the necessary documentation and records to maintain quality control.

To install, calibrate, inspect and repair all levels of instrumentation equipment throughout the facility. Provide process enhancements and continuous improvement as subject matter expert for Calibration. - Leads calibration team, ensuring calibrations are performed on time. - Lead investigations on any calibration related issues. - Manages and provides updated quality metrics. - Provides technical support to manufacturing, engineering and other departments. - Works on assignments that may be complex in nature and where considerable judgment and...

Performs professional, technical laboratory functions.

Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations.  Document all work performed, ensuring accuracy and thoroughness.  Inform management of any deviations from established standards/procedures.