Eurofins

GMP Method Validation Scientist Group Leader (Cell and Gene Therapy)

Boston, MA, US

In-personFull time roleSenior Level

5 days ago

About the Job

We are currently seeking a qualified professional with substantial experience in analytical method development and technology transfer within a GMP-regulated environment whose main job function will be to support our client with GMP-related sample testing and method validation. The individual will also serve as a group leader, overseeing a team of Eurofins PSS employees supporting the client.

Primary Responsibilities:

Execution of complex GMP release and stability assays, such as cell-based functional assays such as PCR, ELISA, and NGS assays.
Technical transfer, qualification, and validation of bioassays used for lot release and characterization of cell and gene therapy products and critical materials.
Author and review SOPs and technical reports.
Work with cross-functional groups within the client environment to participate in various aspects of method development, transfer, process,s and product characterization, comparability, and investigations.
Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.

Leadership Responsibilities:

Supports and monitors the performance of the team of employees
May participate in new hire interviews
Supports the on-boarding process of new employees
Disseminate administrative communications
Demonstrate and promote the company's vision
Ensure adherence to highest quality and efficiency standards in laboratory operations
Ensure coverage and performance for all shifts, and work duties
Performs administrative tasks for team member growth and development
Adeptly balance technical lab work with leadership responsibilities
Foster morale and teamwork

About the Company

Eurofins

Luxembourg, Luxembourg

5000 +

<div class="org-about-module__description"> <div id="ember58" class="ember-view organization-about-module__content-consistant-cards-description"><span class="lt-line-clamp__raw-line">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 the environment safer, healthier and more sustainable. From the food you eat 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 a global leader in food, environmental, pharmaceutical and cosmetic product testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. Since 1987, Eurofins has grown from one laboratory in Nantes, France to ca. 62,000 staff across a network of independent companies in 62 countries, operating over 900 laboratories. Performing over 450 million tests every year, 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, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. Ever since its IPO on the French stock exchange in 1997, Eurofins has been one of the fastest growing listed European companies.</span></div> </div> <div class="org-about-module__content-improvement"> <div class="org-about-module__content-box"> </div> </div>