JOB SUMMARY

The GMP Material Handler – Process Development & Manufacturing Support is responsible for ensuring the timely availability, accurate inventory management, and compliant handling of materials and supplies supporting Process Development (PD) and Manufacturing operations.

This position works closely with Process Development, Manufacturing, Supply Chain, and Quality to coordinate supply orders, track material deliveries, receive and maintain inventory, replenish critical consumables, and support cleanroom material preparation activities.

The ideal candidate is highly organized, detail-oriented, proactive, and comfortable working in a fast-paced, regulated pharmaceutical environment. This is a hands-on role that requires flexibility, a strong service mindset, and a commitment to safety, quality, and operational excellence.

ESSENTIAL JOB FUNCTIONS

Process Development Material & Inventory Support

• Partner with Process Development personnel to identify and maintain materials, laboratory consumables, and supplies needed for development activities.
• Receive incoming PD materials, verify quantities and condition against purchase orders or packing documentation, and enter receipts into the appropriate inventory system.
• Manage post-run, closed client materials; ship back to clients, return to Genezen Inventory, or store in PD inventory
• Organize, label, stock, and maintain PD material storage areas to ensure accessibility, proper storage conditions, and inventory accuracy.
• Proactively communicate material availability and potential shortages that could affect scheduled development activities.

Manufacturing Materials & Consumables Support

• Monitor and maintain inventory levels of general manufacturing supplies, including scrubs, gowning materials, gloves, masks, wipes, cleaning supplies, and other routine consumables.
• Replenish manufacturing supply locations, gowning areas, and approved cleanroom stock locations to maintain operational readiness.
• Maintain designated minimum and maximum inventory levels and initiate replenishment requests to prevent shortages.

• Organize and maintain scrub and gowning inventory in employee locker rooms, including proper stocking, accessibility, and coordination of soiled garment collection and clean garment replenishment.
• Coordinate with Manufacturing personnel to anticipate material requirements for scheduled production activities.
• Maintain clean, orderly, and appropriately stocked storage and staging areas.

Cleanroom Material Handling & Operational Support

• Perform approved sanitization and wipe-down procedures for materials, supplies, and equipment before transfer and handoff to Manufacturing personnel to distribute into designated controlled or classified cleanroom areas.
• Replenish approved consumables in cleanrooms, gowning areas, and production support locations.
• Assist Manufacturing with preparation and staging of supplies and equipment needed for production activities.
• Support approved cleaning and sanitization activities associated with material preparation, equipment transfer, and production readiness.
• Assist with the removal, segregation, and transfer of routine waste from cleanrooms using established waste-handling procedures and approved material/personnel flow routes.
• Follow required gowning, hygiene, aseptic behavior, and cleanroom entry and exit procedures.
• Report material discrepancies, damaged packaging, contamination concerns, or other quality issues promptly.

Documentation, Compliance & Continuous Improvement

• Perform assigned activities in accordance with applicable current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), company policies, and approved SOPs.
• Maintain complete, accurate, and timely records of inventory transactions, material movements, sanitization activities, and other assigned tasks.
• Follow material identification, segregation, quarantine, and release-status requirements.
• Maintain required training qualifications for assigned activities and cleanroom access.
• Follow applicable environmental, health, and safety requirements, including approved chemical handling and waste procedures.
• Identify opportunities to improve inventory accuracy, material availability, workspace organization, and operational efficiency.
• Collaborate with Process Development, Manufacturing, Supply Chain, Quality, and other departments to resolve routine material-related issues.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs.
• Criminal background check required.
• Other duties as assigned.

EDUCATION / CERTIFICATIONS / LICENSES

• High school diploma required
• Associate Degree in Supply Chain or related field preferred

ON-THE-JOB EXPERIENCE

• 1 – 3 years of experience in material handling, inventory management, laboratory support, manufacturing support, warehouse operations, or a related environment
• Experience receiving, stocking, tracking, and organizing materials and supplies
• Previous experience in pharmaceutical, biotechnology, life sciences, medical device, or other regulated manufacturing environments.
• Familiarity with cGMP, GDP, SOPs, and cleanroom practices.
• Experience supporting laboratories, Process Development, or manufacturing operations.
• Experience using ERP, inventory management, purchasing, or warehouse management systems such as Dynamics, SAP, Oracle, or similar platforms.
• Knowledge of inventory controls, cycle counting, lot traceability, expiration-date management, and FIFO/FEFO practices.
• Experience with cleanroom gowning, material sanitization, and controlled-environment material transfers.
• Familiarity with consumables replenishment systems, 5S, or continuous improvement practices.

SKILLS / ABILITIES

• Ability to accurately enter and maintain inventory records using electronic systems or spreadsheets
• Basic proficiency with Microsoft Excel, Outlook, and other standard computer applications.
• Strong attention to detail and ability to follow written instructions and established procedures.
• Effective verbal and written communication skills, including the ability to provide order-status updates and escalate material shortages.
• Ability to prioritize competing requests and work effectively with multiple departments.
• Willingness and ability to complete required GMP, gowning, cleanroom, and safety training.

PHYSICAL DEMANDS

• While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock.
• Occasionally exposed to extremely loud noise levels.

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Ability to lift and/or move up to 40 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail