Job Description

Overview

The Material and Component Scientist plays a critical role in supporting the reliable and compliant manufacture of parenteral drug products. The position focuses on understanding and owning the control strategy related to materials and components—including syringe filling, device assembly, and packaging operations—for commercial products transferring to our clients site in Concord, NC .

This role is not expected to be the technical expert on all products and platforms but will serve as a subject matter expert on regulatory, internal, and external requirements , ensuring a consistent approach across materials-related processes and documentation up to and including regulatory submissions.

Key Responsibilities & Deliverables

• Apply scientific principles to manufacturing of parenteral drug products, device assembly, and packaging, with attention to chemistry, equipment, contact materials, and container closure systems.
• Act as a site SME for high-risk materials (e.g., primary packaging components, raw materials, GMP consumables).
• Assess and document the state of qualification of components using data to demonstrate process capability.
• Develop and maintain technical documentation and material/component specifications .
• Establish critical material attributes and perform supporting studies to define and verify limits.
• Maintain and periodically review materials and consumables used in manufacturing.
• Evaluate the impact of supplier changes on materials, product, and process performance.
• Lead or support technical projects aimed at improving process control, capacity, quality, yield, and material attributes.
• Create and track statistical process control metrics to evaluate process variability and capability.
• Develop and implement a materials technical agenda for parenteral manufacturing.
• Support troubleshooting and continuous improvement efforts related to materials and components.
• Provide technical support for startup activities , including tech transfer and process validation.
• Support non-routine investigations such as deviations or complaints involving materials or container closure integrity.
• Prepare, review, and approve technical documentation, including:
• Change controls
• Regulatory submissions
• Deviations
• Validation protocols/reports
• Procedures, PFDs, VMPs, APRs, QPPAs
• Contribute to regulatory submissions related to product contact materials and container closure.
• Support risk management activities for materials and components.
• Act as a technical liaison with external stakeholders and across the Parenteral Network.
• Provide support for audits and inspections , as needed.
• Maintain a safe working environment by adhering to safety rules and promoting a strong safety culture.

Basic Qualifications

• Education : BS or MS in one of the following (or related) disciplines:
• Material Science/Engineering
• Biochemistry
• Chemistry
• Pharmacy / Pharmaceutical Sciences
• Biochemical or Chemical Engineering
• Experience :
• Data trending and analysis in a manufacturing or technical services environment.

Additional Skills & Preferences

• Strong data analysis and problem-solving abilities.
• Excellent interpersonal and teamwork skills.
• Effective written and verbal communication across all organizational levels.
• Familiarity with parenteral drug product manufacturing and cGMP environments (process development, MSAT, QA, QC, etc.).
• Understanding of container closure systems .
• Knowledge of compendial and international standards (e.g., USP, EP, ICH).
• Proven success in leading cross-functional teams .

Additional Information

• This is a Monday–Friday role with occasional support needed during off-hours based on production schedules, shutdowns, or project timelines.
• Flexibility to work extended hours is required.

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