The Sr. Manufacturing Specialist - Aseptic supports cGMP manufacturing and troubleshoots unexpected manufacturing events, preparing, conducting, and evaluating continued process verification activities; and providing on-going support of commercial and clinical manufacturing. The Sr. Manufacturing Specialist works closely with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position requires superior leadership behaviors and ability to train others.

The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed.

The Scientist II (Chemistry) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist II (Chemistry) position, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing in addition to other key methodologies such as KF and titration. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company) and may also assist with method development / method validation projects.

The Program Manager is accountable for driving results in a fast-paced environment by leading the overall management of “end-to-end” client programs. Services from multiple sites and business areas include a combination of API manufacturing, Drug Product manufacturing, Development Services, and Analytical Services. Travel is required and is dependent on the Program Manager’s home location. The position requires superior leadership behaviors including excellent written and verbal communications, ability to influence others, critical thinking and problem solving, detail and results orientation, ability to understand basic technical detail and regulatory requirements of the customer’s program, and prior work experience in a GMP environment.

The Materials Control Technician is accountable for results in a fast-paced environment by following applicable SOPs and cGMPs to perform tasks for the sampling, physical testing, and sample login of raw materials and packaging components. The Materials Control Technician uses the electronic inventory system to track, document and control all inventory.

The Lead Visual Inspection Technician is accountable for results in a fast-paced environment and responsible for performing tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Lead Visual Inspection Technician handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Lead Visual Inspection Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning, and provides training and coaching to less experienced Visual Inspection Technicians as required. The Lead...

The Visual Inspection Technician I is accountable for results in a fast-paced environment and responsible to perform tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Visual Inspection Technician handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Visual Inspection Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning.

The Buyer I is accountable for driving results in a fast-paced environment by purchasing and negotiating primarily non-manufacturing routine materials, equipment, and supplies from vendors.  The Buyer I evaluates vendor quotes and services to determine the most desirable suppliers.

The Sr. Manufacturing Specialist - Aseptic supports cGMP manufacturing and troubleshoots unexpected manufacturing events, preparing, conducting, and evaluating continued process verification activities; and providing on-going support of commercial and clinical manufacturing. The Sr. Manufacturing Specialist works closely with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position requires superior leadership behaviors and ability to train others.

The Manufacturing Specialist - Aseptic supports cGMP manufacturing and troubleshoots unexpected manufacturing events, preparing, conducting, and evaluating continued process verification activities; and providing on-going support of commercial and clinical manufacturing. The Manufacturing Specialist works closely with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering to ensure robust production of cGMP Sterile Drug Products. The position requires good leadership behaviors and ability to train others.

The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employ acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician I works collaboratively to support other manufacturing areas as required.

The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employ acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician I works collaboratively to support other manufacturing areas as required.

The Automation Engineer is accountable for driving results in a fast-paced environment by being responsible for multiple capital and process improvement related projects. The Automation Engineer’s primary responsibilities will center around: - Evaluating and implementing new ways to automate systems that drives efficiency and compliance. - Testing automation equipment and processes (driving FAT, SAT, and commissioning activities within the Engineering Department and aiding the Validation Department with qualification efforts). - Programming new automated components (i.e. door interlock systems, etc.). - Evaluating existing auto-generated reports for...