Quality Control - Principal Associate Scientist at Eurofins in andover, Massachusetts

Job Description:

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 Organisation 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 Organisations. It also has a rapidly developing presence in highly specialised 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 decentralised 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




Position Description:



We are seeking a highly motivated and skilled candidate for the role of Scientist/Principal Associate Scientist in our Quality Control team. This candidate will be involved in assay optimization and technical transfer of assays into the Quality Control group for our lipid nanoparticle (LNPs) programs. The candidate will be responsible for supporting the in process, release, and stability testing across multiple early phase programs. The ideal candidate will be expected to execute assays independently, support SOP writing and maintain the laboratories in a GMP readiness state. This person should be excited by technical challenges and the ability to grow as a scientist as part of a growing quality team. This position will be based in our client's new state-of-the-art facility in Andover, Massachusetts.



Summary of Key Responsibilities:

• Responsible for running in process, release and stability testing including functional potency, infectious titer, ELISA, quantitative PCR, and cell-based assays.


• Lead the optimization, transfer, and qualification of HPLC and plate-based assays used for viral RNA and lipid nanoparticle (LNP) product release and stability testing.


• Support clinical drug product supply through sample data review, analysis, trending and troubleshooting of QC release and stability methods.


• Collaborate cross-functionally with internal teams to support Process Development, Manufacturing, and Quality organizations.


• 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 regulatory submissions and amendments.


• 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 (+4 years) in Biology, Chemistry, or a closely related field, with post-degree experience in a GMP setting.


• Expertise with HPLC is required.


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


• Experience in a Quality Control group with a strong understanding of cGMP/ICH/FDA/EMA regulations.


• Ability to independently analyze, compile, and present experimental data in oral presentations and technical reports to cross functional groups.


• Hands on experience using and improving Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) 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).


• Ability to lead laboratory investigations, change controls, and deviations and CAPAs.


• Strong organizational and communication skills.

Additional Information



Position is full-time with overtime as needed. Candidates currently living within a commutable distance of Andover, 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.

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