GMP Method Validation Specialist - Group Leader

Job Description

Job DescriptionCompany Description

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!

Job Description

Responsible for the validation of analytical methods—particularly ELISA-based potency assays—in full compliance with Good Manufacturing Practice (GMP) standards. This role ensures that methods are scientifically sound, robust, and suitable for their intended purpose. Additionally, the position plays a critical role in the successful transfer of validated methods, including those developed in R&D, into GMP laboratories for routine use.

Key Responsibilities:

• Design, execute, and document analytical method validation protocols for ELISA-based potency assays and other analytical techniques, following GMP and ICH guidelines.
• Collaborate with R&D scientists to optimize and adapt ELISA methods for GMP applicability, ensuring readiness for validation and transfer.
• Assess method performance characteristics, including specificity, accuracy, precision, linearity, range, and robustness to confirm suitability for GMP environments.
• Generate detailed validation protocols, reports, and regulatory documentation to support audits and compliance inspections.
• Lead and support the technical transfer of ELISA-based assays and other validated methods into GMP laboratories, including training, troubleshooting, and procedural implementation.
• Work closely with cross-functional teams (Quality Assurance, QC, Manufacturing) to ensure seamless method adoption and ongoing compliance.
• Investigate and resolve method-related deviations, participate in root cause analyses, and implement corrective actions as needed.

Leadership Responsibilities

• Supports and monitors the performance of the team of employees
• May participate in new hire interviews
• Supports the onboarding process of new employees
• Disseminate administrative communications
• Demonstrate and promote the company's vision
• Ensure adherence to the 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

Qualifications

Required Qualifications:

• Bachelor’s degree in a scientific discipline with 3–8 years of relevant experience, or a Master’s degree with 2–5 years of experience.
• Demonstrated experience working in a GMP-compliant laboratory environment.
• ELISA, flow cytometry, transfections/transductions, and NGS.
• Hands-on experience in analytical method validation in alignment with industry regulations and ICH/USP guidelines.
• Understanding of GMP practices, regulatory expectations, and industry standards.
• Strong written and verbal communication skills, with the ability to work effectively in cross-functional teams.
• Self-motivated, detail-oriented, and capable of troubleshooting complex laboratory issues independently.
• Prior laboratory supervisory or team leadership experience.
• Authorization to work in the United States indefinitely without restriction or sponsorship

Preferred Qualifications (Nice to Have):

• Experience executing or transferring potency assays (e.g., ELISA, cell-based assays) in a GMP setting.
• Background in cell culture, including work with primary human cells and established cell lines.
• Experience analyzing scientific data using software tools such as JMP.

Additional Information

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.