Manufacturing Specialist 1, Materials
About The Position
Help build and sustain reliable, compliant manufacturing at a world‑class, 24/7 biomanufacturing site. As a Manufacturing Specialist I, Materials, you will be a key driver of operational readiness, daily production excellence, and continuous improvement. This role supports a round‑the‑clock operation and may require flexibility with working hours and shift rotation. You will blend hands‑on support with strong documentation, planning, and problem‑solving to keep production running smoothly and safely. Your work will directly impact product quality, schedule adherence, and the success of technology transfers and inspections.
Requirements
- High School Diploma/GED and 10 years of related experience; OR
- Associate’s degree, preferably in life sciences or engineering, with 8 years of direct experience; OR
- Bachelor’s degree, preferably in life sciences or engineering, with 6 years of direct experience; OR
- Equivalent military experience/training.
- Strong verbal and written communication skills.
- Excellent time management and the ability to prioritize in a fast‑paced environment.
- Adaptability—able to pivot and adjust plans as priorities shift.
- Critical thinking and superior problem‑solving skills.
- A team‑first mindset with the ability to work effectively in a global, cross‑functional environment and build strong relationships.
Nice To Haves
- Strong current Good Manufacturing Practice (cGMP) manufacturing operations experience.
- Solid understanding of operations sequence and cadence of activities.
- Prior experience updating and creating manufacturing documents according to schedule.
- BioWorks or BTEC Capstone cGMP coursework.
Responsibilities
- Support operational readiness initiatives as well as site commissioning and qualification efforts.
- Support troubleshooting, acting as a process subject matter expert for assigned area(s).
- Coordinate batch planning, including process template creation, import, and management of preventive maintenance activities.
- Maintain accurate, current documentation; drive timely updates to records and implement redlines and process improvements.
- Coordinate non‑batch activities, including changeovers, preventive maintenance, and column packing.
- Assist with inventory management and support use of enterprise systems (e.g., SAP) for effective manufacturing operations.
- Support technology transfer within the manufacturing domain.
- Ensure compliance with procedures and safety requirements in the manufacturing environment.
- Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions, and continuous improvement activities.
- Identify and drive improvement projects in drug substance manufacturing.
- Assist and support internal and external inspections and audits to maintain compliance.
- Perform other duties as assigned to meet production and quality objectives.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
