GMP Method Validation Specialist - Group Leader

Responsible for the validation of analytical methodsparticularly ELISAbased potency assaysin 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 ELISAbased 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 ELISAbased assays and other validated methods into GMP laboratories including training troubleshooting and procedural implementation.
• Work closely with crossfunctional teams (Quality Assurance QC Manufacturing) to ensure seamless method adoption and ongoing compliance.
• Investigate and resolve methodrelated 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 companys 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:

• Bachelors degree in a scientific discipline with 38 years of relevant experience or a Masters degree with 25 years of experience.
• Demonstrated experience working in a GMPcompliant laboratory environment.
• ELISA flow cytometry transfections/transductions and NGS.
• Handson 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 crossfunctional teams.
• Selfmotivated detailoriented 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 cellbased 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 fulltime and permanent MondayFriday 8 am5 pm with overtime as needed. Candidates living near or in Cambridge MA are encouraged to apply.

Excellent fulltime 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 awardwinning insourcing solution that places our people at our clients sites dedicated to running and managing laboratory services while eliminating headcount coemployment and projectmanagement worries.

We infuse our 55year 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 .

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

Remote Work :

No

Employment Type :

Fulltime