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
Job description
- In this exciting opportunity, you will be designing and executing various laboratory experiments to support development, validation and transfer of analytical methods for monitoring process related impurities in Biologics.
- You will be also authoring, reviewing and/or approving technical documents or regulatory filings ensuring high technical standards and compliance with applicable regulatory guidelines to support analytical impurity methods (protocols, reports, test methods, etc).
- This role will have you assisting in evaluation and the following implementation of new technologies.
Candidates should have familiarity with several of the below laboratory techniques; they should also possess expertise with the following:
- Development, validation and transfer of analytical impurity methods to support biological product release
- Mentoring and Training junior scientists on relevant laboratory techniques and instrumentation relating to measurement of process related impurity assays
- Support in the lab or oversee characterization of critical reagents (Antibodies, conjugated antibodies, assay controls, calibration standards) using a variety of fundamental biochemical methods including:
- ELISA
- 1 and 2D Gel Electrophoresis
- Western Blot
- HPLC/LCMS
- Supporting troubleshooting and assay remediation activities based on significant technical expertise in plate-based impurity methods and fundamental understanding of analytical development principles.
- Responsible for documentation of development and validation data, generation of high-quality written study protocols, reports, and leading cross functional meetings
- Responsible for maintaining awareness of current regulatory guidelines that may apply to methods being validated (ICH quality guidelines etc).
- Responsible for documentation of development and validation data, generation of high-quality written study protocols, reports, and leading cross functional meetings
Qualifications
Degree in Chemistry, Biochemistry, Biology or other related discipline with minimum additional years of relevant industry experience in Analytical Development or related function:
- BSc and 8+ yrs industry experience
- MSc and of 6+ yrs industry experience
- PhD and 2+ yrs industry experience
Demonstrated hands on experience working on development of plate based impurity methods including process specific host cell protein (HCP) ELISA, residual DNA methods (qPCR, dPCR), residual Protein A methods, Octet methods, is essential.
Additional Information
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.
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