Assay Development Laboratory Scientist

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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It 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 Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer 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 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

The Laboratory Scientist is responsible for development and validation of new methods within the clinical laboratory which may involve various disciplines including, but not limited to ELISA, PCR, Flow Cytometry, HPLC/MS and as well as contributing to multiple projects with little supervision. The Laboratory Scientist will act as a project manager within the laboratory, clearly communicating with management, quality assurance and vendors to ensure on time and accurate deliverables.

Key Accountabilities

•  Research literature and sources, develop plans for validations and perform method validations, maintaining appropriate documentation throughout process.
•  Assist management in the writing of procedures (SOPs) and training of technical staff on validated methods.
•  Perform statistical analysis and generate validation reports per relevant GCP guidelines.
•  Contribute to the sales process with timely, competent answers to RFI’s and proposals.
•  As needed: perform laboratory testing according to established global protocols, timelines and procedures (SOPs) to generate high-quality, error-free, analytical results. Maintain equipment and perform QC procedures within established guidelines, keeping appropriate documentation.
•  Report deviations, perform and document corrective and preventative actions to support QA.
•  Assure full laboratory compliance with federal (CLIA, CAP) and state requirements and where needed, maintain GLP compliance (e.g. FDA and OECD GLPs).
• From time to time, perform other lab-related duties as delegated by management, including inventory, archiving and safety tasks, acting as a reliable back-up to colleagues on leave.

Qualifications

Experience

Minimum 2 years of complex laboratory method development, validation and testing in a diagnostics, clinical laboratory

Education

• Bachelor Degree in Biology, Chemistry, Microbiology or related scientific field.
• Master preferred
• Hands on experience with additional analytical techniques including HPLC, ELISA, qPCR/dPCR, preferred.
• Hands on experience with microbiological techniques including bioburden and endotoxin is preferred.
• Experience in a Quality Control group with a strong understanding of cGMP/ICH/FDA/EMA regulations

Other

• Proficient in English, both written and verbal.
• Ability to set priorities and work accurately under deadlines.
• Prolonged usage of analytical and computer systems (>75% time).
• Proficient in good laboratory and documentation practices.
• Ability to multi-task with different instrumentation.
• Competency with EP Evaluator and Microsoft Office Suite.
• Good interpersonal skills.
• Ability to work flexible hours.
• Capable of identifying problems and escalating as appropriate.

Additional Information

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Pai