Reagent Manufacturing Manager

Alveo is looking for a highly skilled manufacturing professional who will be responsible for developing and managing our internal Reagent Manufacturing operations. In your role, you will manage a small and growing team of reagent manufacturing staff, assist with development of production strategies to meet reagent supply requirements, while implementing and managing related production environments and process improvement initiatives.  

You Will: 

·       Build and lead a team of production experts in a GMP/GLP formulations/compounding lab 

·       Manufacture reagents and buffers in compliance with cGMP, cGLP, GDP, QSRs, ISO and IVD regulations. 

·       Establish production management controls, tools, and reporting to ensure stable and reliable supply, and consistent quality of product.  

·       Work closely with supply chain to capture demand requirements, plan and manage raw materials supply, and prepare for varying capacity needs. 

·       Develop and implement programs and processes to deliver reagents that consistently meetspecifications and quality requirements batch-after-batch.  

·       Lead trend analyses for performance metrics including product key characteristics, manufacturing yields, production throughput, and costs. 

·       Drive root cause corrective action to address product discrepancies.  

·       Develop and implement programs to reduce costs and improve production efficiency for all reagent production environments.  

·       Develop inventory management programs based on product life cycle, shelf-life, and storage environments.  

·       Ensure compliance and consistent record-keeping in the Quality Management System (QMS), product lifecycle management (PLM) software, and enterprise resource planning(ERP) system. 

·       Adhere to best safety practices and documented procedures to ensure a safe working environment, including use of PPE

Your Background Should Include: 

·       Bachelors or Associates Degree (BA, BS, AS, AAS) with a focus on chemical and/or biological sciences required 

·       5+ Years related experience in a GMP/GLP formulations/compounding lab required 

·       Demonstrated effective leadership and communication skills with the ability to inspire and motivate team members  

·       Must be able to work in a fast-paced environment, managing multiple competing priorities and assignmentswith the ability to plan and deliver against deadlines 

·       Strong computer, scientific, and organizational skills with attention to detail 

·       Experience with statistical analysis tools a plus 

·       Strong written and verbal communication skills required 

·       Strong laboratory skills including pipetting, safety, and hazardous materials handling, and working in a BSC is required 

·       Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies 

·       Familiar with cell and nucleic acid amplification assays 

·       Extensive understanding of basic laboratory equipment 

·       Inventory management skills 

·       Basic knowledge of Lean initiatives 

Salary range is $116,200 - $137,800 per year