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

Eurofins • Cambridge, MA • 21h ago

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products 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.

If you're looking for a rewarding career, apply with us today!

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

Bachelor's degree with 3-8 years of experience

Master's degree with 2-5 years of experience

Proficient experience in validating analytical methods in compliance with GMP standards.

Hands-on experience with the successful transfer of methods into GMP laboratories.

Hands-on experience with sample testing in a GMP laboratory.

Solid understanding of regulatory expectations (e.g., FDA, EMA) concerning method lifecycle management.

Team player with excellent oral and written communication skills

Independently motivated, detail-oriented, and excellent problem-solving abilities.

Laboratory supervisor experience is preferred

Experience with potency assays (e.g., cell-based assays, ELISA) is advantageous but not essential.

LIMS experience is a plus

The position is full-time and permanent, Monday-Friday, 8 am-5 pm, with overtime as needed. Candidates living near or in Cambridge, MA, are encouraged to apply.

Excellent full-time benefits include:

Comprehensive medical coverage, dental, and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients' sites, dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR, and a great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our clients' quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

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