Lead Manufacturing Associate-LAN

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Execute tasks per CGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing training program. Actively incorporate the Shared Values set out by Emergent Bio Solutions while performing day to day activities.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Complete training and demonstrate competency on Lead Manufacturing Associate qualification blocks in accordance with the training progression pathway
• Execute and document procedural steps in compliance with CGMP standards, clean room behavior and Standard Operating Procedures
• Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as CGMP, GDP, EH&S regulations, and company regulations such as the employee handbook
• Maintain state of facility environmental control including preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing areas per Standard
• Operating Procedures
• Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform "real time" review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift
• Stock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials
• Perform bubble point integrity testing of hydrophilic and hydrophobic production filters using defined test programs
• Ensures that all Batch Production Records are requested and obtained in accordance with the production schedule
• Verification of Facilities department execution of preventive maintenance of equipment. Requires thorough understanding of GMP equipment operation and function for intended purpose

• Proactively recognize potential issues with manufacturing process equipment and troubleshoot in collaboration with Facilities/Maintenance
• Make decisions and elevate manufacturing and quality issues to management in a timely and effective manner
• Participate in self inspections and 6S audits and respond to findings
• Show personal commitment and acts to continuously improve
• Builds networks and engages in/runs meetings
• Holds self-accountable as well as peers
• Displays strong core values and cultural responsibilities
• Capable of scheduling and coordinating daily tasks

• Contribute to the development and promotion of standard work
• Collaborate with applicable Integrated Process Teams to drive continuous improvement and learn new Lean concepts
• Oversee and actively participates in Kanban and 6S systems
• Identify continuous improvement opportunities and collaborates with Integrated Process Teams and Supervisors to drive initiatives through to completion

• Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification)
• Independently operate labeling equipment with minimal supervision (Qualification)
• Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation)
• Package…