Manufacturing Associate-LAN

Emergent Biosolutions • Lansing, MI

6d • $39,000 - $47,100

About The Position

The Manufacturing Associate executes tasks in accordance with current Good Manufacturing Practices (CGMP) and Standard Operating Procedures to manufacture, inspect, and package Anthrax Vaccine Adsorbed. The role includes completing required training and maintaining competence under the manufacturing training program, while incorporating Emergent BioSolutions’ Shared Values into day-to-day work.

The associate performs and documents manufacturing activities in controlled areas, maintains facility environmental controls and supplies, reviews records in real time, and participates in Lean and continuous-improvement programs. Responsibilities span inspection and packaging, preparation activities, upstream fermentation operations, and downstream processing. Work includes operating and cleaning production equipment, preparing materials, handling process transfers, monitoring culture parameters, collecting samples, and documenting activities using applicable systems.

The role requires compliance with CGMP, GDP, FDA, environmental health and safety, and company requirements. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The stated salary range for new hires is $39,000 to $47,100 annually; individual pay may vary based on factors including education, experience, skills, abilities, internal equity, market data, and geographic location. Certain roles may also be eligible for incentive compensation, including merit increases, an annual bonus, and/or long-term incentives in the form of stock options. Emergent offers a comprehensive benefits package, with eligibility governed by applicable plan documents and policies.

Requirements

• High school diploma.
• 1–2 years of experience working in a CGMP environment.
• Personal competencies: self-awareness, integrity, teamwork, creativity, and cultural awareness.

Nice To Haves

• Knowledge of CGMP and CFR requirements.

Responsibilities

• Complete manufacturing qualification training and demonstrate competency in accordance with the training progression pathway.
• Execute and document procedural steps in compliance with CGMP standards, cleanroom behavior requirements, and Standard Operating Procedures.
• Comply with applicable Emergent and pharmaceutical/biotech industry rules and regulations, including FDA CGMP, GDP, EH&S, and company requirements.
• Maintain facility environmental controls, prepare specified cleaning-solution concentrations, and conduct scheduled cleaning of manufacturing areas.
• Review process documentation for accuracy and completeness as steps are completed, including real-time review of batch records, forms, and logs.
• Restock gowning and consumable supplies in controlled areas and maintain Kanban inventory control of manufacturing materials.
• Follow standard work guidelines and participate in Integrated Process Teams, continuous improvement, Kanban, and 6S programs.
• Qualify as an inspector and identify, classify, and cull product defects, including defects that could affect patient safety.
• Operate labeling equipment with minimal supervision after qualification.
• Apply traceability and expiration information to secondary packaging components and inspect printed cartons and cases for suitability.
• Package product in secondary and final packaging components and reconcile product rejects.
• Complete ambient tracking documentation and use specified SAP modules to issue materials and confirm process steps.
• Precisely weigh and hydrate media components; load, operate, and unload parts washers and sterilization/decontamination equipment using validated configurations.
• Assemble clean process glassware configurations and portable tanks using sanitary connections, quick connects, and stainless-steel ancillary parts.
• Clean and sterilize production vessels through automated control systems, and prepare and dispense intermediate materials.
• Execute upstream production tasks, including cleaning and sterilizing fermenters, sterilizing media filters, inoculating fermenters, monitoring culture turbidity, transferring culture between vessels, adjusting culture pH, and filtering culture into a harvest tank.
• Install sterilizing-grade filters, perform integrity testing, and sterilize filter skids.
• Add ALOH to the harvest tank, draw and submit samples through LIMS, and clean and sterilize harvest tanks.
• Clean and sterilize centrifuges and run centrifugation processes; dispense and sterilize ALOH.
• Demonstrate the stated cultural competencies, including collaboration, effective communication and conflict management, innovation, accountability, sound decision-making, customer focus, integrity, problem-solving, planning, prioritization, and engagement.

Benefits

• Comprehensive benefits package; details are available on the company careers website and eligibility is governed by applicable plan documents and policies.
• Certain roles may be eligible for merit increases, an annual bonus, and/or long-term incentives in the form of stock options.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED