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Production Materials Lead

August Bioservices
Posted 4 months ago, valid for 14 days
Location

Nashville, Davidson 37242, TN

Salary

Competitive

Contract type

Full Time

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Sonic Summary

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  • August Bioservices, a high-growth Contract Development Manufacturing Organization based in Nashville, TN, is seeking a Production Materials Lead with 2-4 years of experience in a pharmaceutical or regulated industry.
  • The role involves coordinating and managing the availability of materials for manufacturing operations while ensuring compliance with GMP standards.
  • Key responsibilities include material coordination, staging, reconciliation, and cross-functional collaboration with Supply Chain and Quality Assurance teams.
  • Candidates should have a high school diploma or GED, with a bachelor's degree preferred, and experience with ERP systems like SAP or Oracle.
  • Salary details are not provided, but the company emphasizes a dynamic work environment focused on global health and continuous improvement.

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO).  As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!


The Production Materials Lead is responsible for coordinating, managing, and ensuring the availability and timely staging of materials required for manufacturing operations within a small pharmaceutical CDMO environment. This role serves as a key liaison between Supply Chain, Quality, Warehouse, and Production to ensure timely and compliant material flow aligned with GMP (Good Manufacturing Practices) standards.  This position is also responsible for reconciliation of materials that are returned from production and ensuring that they are returned to inventory or discarded per procedure in a timely manner.

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Responsibilities
  • Material Coordination & Staging
    • Ensure timely availability of raw materials, components, and consumables for production schedules
    • Stage and verify materials (quantities, lot numbers, etc.) for manufacturing batch execution in accordance with batch records
    • Stage inventory for cleanroom materials replenishment
    • Review production schedules and proactively identify material gaps or risks
    • Collaborate with Supply Chain and Planning to align material supply with manufacturing demand.
    • Ensure timely reconciliation of materials returned from production, returning to inventory or discarding promptly.
  • Production Support
    • Ensure materials are properly labeled, released, and compliant with GMP requirements
    • Act as primary point of contact for material-related issues on the production floor, minimizing downtime associated with materials issues.
    • Coordinate the receipt of finished goods into inventory post-manufacturing.
    • Inspecting materials for damage, ensuring proper labeling, and managing temperature-sensitive materials (e.g. cold storage or frozen products) with immediate priority.
  • Documentation & Compliance
    • Maintain accurate records for material transactions, ensuring accuracy in both in MRP/ERP systems and all other cGMP documentation
    • Strict adherence to cGMP and Good Documentation Practices, setting the example for good documentation practices and inventory accuracy.
    • Ensure compliance with cGMP, SOPs, and regulatory requirements
    • Support audits and inspections by providing material traceability documentation
  • Inventory Control & Tracking
    • Using ERP or similar systems, monitor inventory levels and support cycle counts and inventory accuracy initiatives
    • Track material usage and reconcile discrepancies
    • Support inventory optimization to minimize waste and stockouts
  • Cross-Functional Collaboration
    • Work closely with Quality Assurance for material release and deviations
    • Coordinate with Warehouse for material receipt, storage, and issuance
    • Communicate effectively with Manufacturing, QC, and Supply Chain teams
  • Continuous Improvement
    • Identify and implement process improvements in material handling and flow
    • Support lean manufacturing and operational efficiency initiatives
    • Participate in deviation investigations and CAPA implementation related to materials


Qualifications
Education & Experience:
  • High school diploma/GED or equivalent required.  Bachelor’s Degree preferred.  Equivalent combinations of education, training, and relevant work experience may be considered.
  • Experience in material coordination, inventory control, or production support
  • Experience with ERP systems (e.g., SAP, Oracle, NetSuite, etc.)
  • Regular and predictable on-site attendance.
  • 2-4 years of experience in a pharmaceutical, biotech, or CDMO manufacturing environment or other regulated industry preferred
Knowledge, Skills & Abilities:
  • Strong understanding of cGMP regulations and material control processes
  • Excellent organizational and problem-solving skills
  • Basic computer knowledge
  • Intermediate math skills
  • Ability to manage multiple priorities in a fast-paced, small-company environment
  • Strong communication and cross-functional collaboration skills
  • Detail-oriented with a focus on accuracy and compliance.
  • Ability to follow SOPs, document clearly, and timely.
Physical Requirements
  • Light work – exerting up to 40 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.  Reaching upward and downward, push/pull, stand, Visual Acuity with or without corrective lenses.
  • Climbing stairs/ladders, kneeling/crawling, sitting, stooping/squatting.  Finger feeling, handling, push/pull, reaching upward and downwards, standing, walking
  • Must be able to lift up to 40 pounds at times.
  • Forklift certification preferred.


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At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

 

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!


August Bioservices  is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.




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