Principal Scientist (Analytical Method Development & CRO Study Management)
Eurofins

Job Info

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Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

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.
  

Qualifications

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).
  

Additional Information

Position is full-time, Monday through Friday, 8am-5pm with overtime as needed. Candidates currently living within a commutable distance ofLexington, MAare 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 aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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

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