Group Leader – Potency Assays & ELISA (GMP Environment)

Were looking for a collaborative solutionsoriented scientific leader to join our team as a Group Leader specializing in potency assay development and transfer. This role is ideal for someone with deep experience in ELISA and cellbased assays who thrives on translating scientific methods into robust compliant processes in a GMPregulated setting.

As the technical SME for mRNA and gRNA potency assays youll be instrumental in supporting a range of client programsguiding the transition from R&D to GMP with quality clarity and confidence.

Key Responsibilities: Potency Assay Development & GMP Transfer

• Lead the transfer optimization qualification and validation of potency assays into a GMP environment for lot release and product characterization.
• Serve as a Subject Matter Expert (SME) in ELISAbased and functional assays with a focus on technical troubleshooting and method robustness.
• Oversee and execute advanced bioanalytical methods such as cellbased assays ELISA ddPCR flow cytometry and NGS.
• Draft and review critical documentation including SOPs protocols and technical reports in compliance with regulatory standards.
• Collaborate with crossfunctional teams to support method development process understanding and assay lifecycle management.
• Monitor and analyze assay performance to ensure consistency and ongoing GMP readiness.

Leadership Responsibilities: People Process & Purpose

• Guide and support a team of talented scientists and analystsfostering growth engagement and accountability.
• Play a key role in onboarding new team members sharing best practices and promoting a collaborative lab culture.
• Ensure efficient lab operations and adherence to the highest GMP quality standards across all shifts.
• Actively contribute to hiring team development and performance management.
• Balance technical work with leadershipsetting an example in both scientific rigor and team collaboration.

Qualifications :

Minimum Qualifications:

• Bachelors degree with 38 years of experience or Masters degree with 25 years in a related scientific field.
• Proven experience in potency assay execution especially ELISA and cellbased assays.
• Handson experience working in a GMP laboratory setting.
• Solid understanding of industry practices quality standards and regulatory expectations.
• Excellent written and verbal communication skills; able to collaborate across teams.
• Highly motivated detailoriented and strong in analytical thinking and problemsolving.
• Previous lab leadership or supervisory experience is preferred.

Preferred Skills:

• Expertise in cell culture including both established lines and primary human cells.
• Experience with assay transfer into GMP environments.
• Familiarity with a broad range of analytical techniques:
  • Transfections/transductions
  • ddPCR/qPCR
  • Flow cytometry
  • ELISA
  • Nextgeneration sequencing (NGS)
• Proficiency with data analysis tools such as JMP.
• Working knowledge of ICH/USP guidelines.

Additional Information :

What to Expect in the Hiring Process: 

• 1015 Minute Phone Interview with Region Recruiter
• 4560 Minute Virtual Interview with Manager and/or Group Leader
• 60 Minute In Person Meeting 

Additional Details: 

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