Senior Manufacturing Associate

In this role, you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including formulation, sterile‑isolator filling, aseptic filling, and lyophilization activities. The team leads the efforts of maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. The Associate will work to support multiple internal customers and partners including Supply Chain, Quality Assurance, Process Development, and Engineering.

• Executing drug product filling activities
• Performing initial review of manufacturing batch records
• Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures
• Crafting and/or revising standard procedures
• Leading continuous improvement initiatives, which may be multi‑functional in nature
• Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
• Developing finite schedule for tasks including, unit operations
• Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment
• Elevating critical and impactful events to management
• Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
• Supporting the introduction of new products and technologies into the facility
• Initiating and owning quality records, including but not limited to non‑conformances (NC), Corrective/Preventative Actions (CAPA)

• Bachelor’s degree and 2 years of experience
• Associate’s degree and 4 years of experience
• High school diploma / GED and 6 years of experience

• GMP Knowledge
• Project Management
• Cross Functional Team Building

• Prior pharma experience
• Data visualization skills, Excel