Principal Scientist (Analytical Method Development & CRO Study Management)

Summary of Key Responsibilities: 

• Responsible for managing and running Method development, validation, and qualification projects for plate based ELISAs and quantitative PCR 

• Lead the development, optimization, and qualification of impurity ELISAs. 

• Have strong understanding of ICH guidelines regarding host cell proteins(HCPs). 

• Support and manage external CRO studies by reviewing validation and qualification data, methods, and reports. 

• Independently analyze, compile, and present data in oral presentations to cross functional teams. 

• Write and review SOPs, analytical test methods, protocols, and reports. 

• Author and review Development reports, qualification reports, test methods, SOPs, etc. 

• Mentor junior staff and oversee laboratory activities including but not limited to equipment maintenance and managing critical reagent inventory. 

Preferred Experience and Skills: 

• Bachelor’s (+6 years), Master’s (3-7 years, or PhD (3-4 years) in Biology, Chemistry, or a closely related field 

• Expertise with plate-based assays is required, specifically ELISAs. 

• Hands on experience with additional analytical techniques including ELISA, qPCR/dPCR, CE preferred. 

• Strong understanding of cGMP/ICH/FDA/EMA regulations. 

• Experience leading qualification and/or validation for plate based assays.  

• CRO Project/Study management experience preferred. 

• Understanding of statistical concepts and working knowledge of software packages commonly used for data analysis and visualization (e.g. MS Excel, GraphPad, and JMP).

Position is full-time, Monday through Friday, 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Lexington, MA are encouraged to apply. 

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options 

• Life and disability insurance 

• 401(k) with company match 

• Paid vacation and holidays 

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. 

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.