With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Raw Material Sampling Coordinator is responsible for the controlled sampling of incoming GMP raw materials and components following receipt and quarantine, and for the timely transfer of representative samples to Quality Control (QC) for testing and disposition. This role performs sampling activities in approved sampling areas using qualified equipment, approved procedures, and appropriate personal protective equipment to protect sample integrity, prevent contamination and cross-contamination, and maintain complete traceability.

The Raw Material Sampling Coordinator serves as the operational link between Materials Management and Quality Control for incoming material sampling. The position reviews sampling requirements, coordinates priorities, performs and documents sampling, maintains chain of custody, completes applicable ERP and/or LIMS transactions, and returns sampled materials to the appropriate controlled storage status. The role also supports deviation investigations, audit readiness, housekeeping, and continuous improvement while maintaining compliance with cGMP, Abzena procedures, and data integrity expectations.

Responsibilities

Support and ensure compliance with 21 CFR, cGMP regulations, Abzena's Quality Management System (QMS), Standard Operating Procedures (SOPs), approved material specifications, sampling plans, and all applicable company policies.

Review incoming material receipt documentation, material status, lot information, container counts, and applicable sampling requirements before initiating sampling activities.

Coordinate daily raw material sampling priorities with Materials Management, Quality Control, Supply Chain, and Manufacturing to support material release and manufacturing readiness.

Inspect incoming material containers for identity, labeling, seal integrity, damage, cleanliness, and other visible conditions that could affect material quality or sampling suitability, and escalate discrepancies before sampling.

Stage and move quarantined raw materials into approved sampling locations while maintaining material status segregation, traceability, required environmental conditions, and appropriate handling controls.

Perform representative raw material sampling using approved procedures, sampling tools, qualified equipment, and required PPE while minimizing contamination, cross-contamination, and exposure risk.

Perform aseptic or controlled sampling activities in a biological safety cabinet, sampling booth, or other qualified area when required by the material, specification, or procedure.

Accurately label sample containers and document sample identity, material code, supplier lot, internal lot, quantity, sampling date, sampler identification, and other required traceability information.

Maintain sample chain of custody from collection through handoff to QC or an approved external testing laboratory, including timely delivery under required storage or temperature conditions.

Complete required ERP, inventory, LIMS, logbook, and controlled documentation transactions accurately and contemporaneously in accordance with data integrity and good documentation practice requirements.

Ensure sampled source containers are properly resealed, relabeled as required, and returned to the correct quarantine or controlled storage location with material status maintained.

Support retain sample activities, sample reconciliation, sample inventory, and disposition activities when assigned.

Clean, sanitize, and maintain sampling areas, equipment, tools, and associated supplies in an inspection-ready condition according to approved procedures.

Monitor sampling consumables, PPE, labels, containers, and equipment availability and escalate shortages or equipment issues that could delay sampling or QC testing.

Initiate or support deviations, investigations, CAPAs, change controls, and other quality records associated with sampling errors, damaged materials, documentation discrepancies, environmental concerns, or procedural nonconformance.

Support internal audits, client audits, and regulatory inspections by providing sampling records, demonstrating approved processes, and maintaining areas and documentation in an inspection-ready state.

Participate in continuous improvement activities focused on sampling turnaround time, right-first-time documentation, sample traceability, material flow, safety, and operational efficiency.

Provide task-specific training and practical guidance to qualified personnel on approved raw material sampling practices when assigned.

Perform other duties as assigned to support Abzena business and operational needs.

Qualifications

High school diploma or equivalent required. Associate's or Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, Supply Chain, or a related field preferred.

Minimum of two (2) years of experience in pharmaceutical, biotechnology, laboratory, warehouse, materials management, or other regulated operations preferred, with direct GMP raw material sampling experience strongly preferred.

Working knowledge of cGMP requirements, good documentation practices, material status control, traceability, chain of custody, and contamination prevention.

Hands-on experience with raw material sampling tools, balances, sampling booths, biological safety cabinets, or controlled sampling environments preferred.

Ability to follow material specifications, sampling plans, SOPs, safety data sheets, and written work instructions with a high degree of accuracy.

Experience with ERP/MRP and/or LIMS systems preferred. Experience with IFS, SAP, or equivalent systems is a plus.

Experience handling temperature-sensitive, hazardous, or controlled raw materials preferred, including the ability to use required PPE and follow site EHS requirements.

Strong attention to detail and demonstrated ability to maintain accurate, contemporaneous, and traceable GMP documentation.

Ability to identify discrepancies, stop work when conditions are not acceptable, and escalate quality, safety, or material integrity concerns promptly.

Strong organizational, communication, and collaboration skills with the ability to manage changing priorities and coordinate effectively with QC and Materials Management.

Ability to work independently after qualification and provide flexible coverage to support material receipts, QC testing schedules, and manufacturing readiness.

Forklift or powered industrial truck certification preferred where material movement is part of the assigned duties, or the ability to obtain certification.

Travel between Abzena sites (Bristol PA, San Diego CA, and Cambridge UK) as needed.

Physical Requirements:

Ability to stand for 1-2 hours at a time and sit for 2 to 3 hours at a time.

Frequently lift and/or move objects weighing at least 15 pounds; occasionally lift or move heavier materials with appropriate assistance or equipment.

Use arms, hands, and fingers to handle, feel, reach, manipulate sampling tools, and perform detailed labeling and documentation activities.

Ability to climb, balance, stoop, kneel, crouch, or reach as required for material access and sampling activities.

Visual abilities including near and far sight, color recognition, peripheral vision, depth perception, and the ability to focus.

Ability to wear required PPE, including gowning and respiratory protection when applicable to assigned sampling activities.

FLSA: Non-Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.