Reagent Manufacturing Scientist

Codetta Bio is a venture-backed life sciences company with innovative solutions to some of the most significant challenges in the life sciences and healthcare industries. We are developing advanced multi-omic biomarker measurement tools supporting data-driven approaches to understanding the unique genetic, environmental, lifestyle, and clinical factors that contribute to individual health and wellness. Guided by an experienced leadership team, Codetta offers a high-energy, collaborative work environment with opportunities for professional advancement. 

The ideal candidate will be self-motivated, organized with excellent communication skills, as well as excellent writing skills. As this position relies heavily on working with a cross-functional team, time flexibility is important. The candidate must be comfortable in a fast-paced environment where everyone holds each other accountable and have the flexibility to meet during normal work hours and alternative hours as needed. 

Major Responsibilities:

• Responsible for manufacturing key bead-based reagents for Codetta Bio product lines 
• Works with cross-function team to develop, qualify and validate methods to support reagent characterization and product release 
• Optimizes reagent manufacture methods and contributes to improvement of process efficiency 
• Responsible for maintaining appropriate documentation, including Batch Records, compliant with ISO9001 and GMP regulations electronically, and via paper record, as indicated  
• Supports final product quality control 
• Present data at regular meetings and contribute to scientific publications  
• Occasional evening or weekend work when required 

Required Qualifications:

• BS, or MS in chemistry, biochemistry, chemical engineering or related field 
• 2 years experience working in biological reagent manufacturing, preferably in industry 
• Direct experience with buffer formulation, general lab techniques (pipetting, use of pH meter, analytical balances, volumetric glassware), preferably in industryDirect experience with conjugation of protein and nucleic acids as well as surface (bead or other assay solid support) functionalization methods 
• Exceptional organization skills and attention to detail 
• Ability to work independently and manage time effectively 
• Excellent written and verbal communication skills 
• Collaborative and team-oriented 

Preferred Qualifications:

• Demonstrated knowledge and understanding of GMP, QA and QC functions associated with the manufacturing of assay-related products and compliance with ISO 9001 or similar. 
• BSL-2 laboratory experience 
• Direct experience with conjugation of protein and nucleic acids as well as surface (bead or other assay solid support) functionalization methods 
• Direct experience with PCR and immunoassay methods and instruments 
• Direct experience with ELNs, Benchling or similar 

 

 

Work Location: 

• On-site in Morrisville, NC