Preparedness today, safer tomorrow.

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

JOB SUMMARY

This Manufacturing Associate role is a limited term position scheduled to end in September 2027. 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 BioSolutions while performing day to day activities.

ESSENTIAL

FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. GeneralComplete training and demonstrate competency on Manufacturing Associate qualification blocks in accordance with the training progression pathwayExecute and document procedural steps in compliance with CGMP standards, clean room behavior and Standard Operating ProceduresComply 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 handbookMaintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing areas per StandardOperating ProceduresReview 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 shiftStock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials Lean ConceptsFollow standard work guidelinesCollaborate with applicable Integrated Process Teams to participate in continuous improvement and learn new Lean conceptsActively participate in Kanban and 6S programs Inspection and PackagingSuccessfully 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 product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging)Complete ambient tracking documentationExecute material issuance and confirmation of process steps using specific SAP modules Building 55 Operations - PrepExecute material issuance and confirmation of process steps using specific SAP modulesPrecisely weigh and hydrate media componentsLoad, run and unload parts washer and sterilization/decontamination using specific validated load configurations per Standard Operating ProceduresAssemble clean process glassware configurations and portable tanks utilizing sanitary connections, quick connects and stainless-steel ancillary partsPerform Cleaning (COP/CIP) and Sterilizing (SOP/SIP) of production vessels through interface with automated control system (DeltaV)Prepare and dispense intermediate materials Building 55 Operations - UpstreamExecute detailed manual and high impact process tasks requiring extensive documentation and interface with automated controls. Process operation involves manual orientation of valve configurations and monitoring/adjustment of vessel pressures during execution to maintain the sterile envelope and create differentials to facilitate transfers.

Description of specific requirements include:

Clean and Sterilize 10L, 120L and 1320L fermenters to defined and validated parameters through interface with automated control systemSterilize media filters and sterile filter seed, intermediate and production mediaInoculate 10L fermenter through addition of inoculum via peristaltic pumpMonitor culture turbidity to verify growth to required process parameters and transfer culture from the 10L to 120L and the 120L to 1320L fermenters upon verification of achievement of these parametersAdjust pH of culture through manual addition of 2N NaOH aliquots to a defined pH rangeInstall sterilizing grade filters, perform integrity testing and execute sterilization of filter skidMonitor culture turbidity to verify growth to required process parameters and filter culture from 1320L fermenter to Harvest Tank Building 55 Downstream OperationsAdd ALOH to Harvest tank.

Draw samples and submit them through LIMS.Clean and sterilize Harvest TanksClean and sterilize centrifuge as well as run the centrifugation processesDispense and sterilize ALOH Behavior/Cultural ResponsibilitiesStanding Shoulder to Shoulder (no matter what):working collaboratively with others, communicating, and managing conflict effectively

Break Through Thinking:

cultivating innovation and nimble learning

Own It Always:

ensuring accountability, and making good and timely decisions

Compete Where It Counts:

demonstrating courage and focusing on customers

Integrity and Instills Trust:

gaining the confidence and trust of others through honesty, integrity and authenticityManages... For full info follow application link. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.