Stability Protocol Writer

Eurofins Lancaster Laboratories is seeking a detail‑oriented and highly organized Stability Protocol Writer/Study Builder to join our team. This role is critical in supporting our stability program operations by transforming client requirements and Eurofins‑generated quotes into accurate, compliant protocols and complete study builds within the LIMS system.

 

The ideal candidate is comfortable navigating complex technical documents, working with cross‑functional teams, and ensuring all study components are aligned with Good Manufacturing Practices (GMP) and internal quality standards.

 

Key Responsibilities

• Translate Eurofins‑generated quotes into fully developed, compliant stability protocols within the LIMS system.
• Build stability studies based on client‑provided protocols, ensuring all parameters are configured accurately.
• Collaborate with Project Management, Study Management, and Laboratory teams to ensure protocols and studies reflect correct requirements and timelines.
• Verify that protocol content aligns with regulatory expectations, internal SOPs, and client specifications.
• Maintain meticulous documentation and version control throughout protocol creation and study build processes.
• Identify and communicate any discrepancies or missing information to internal stakeholders or clients.
• Support continuous process improvements related to protocol writing, workflow efficiency, and system utilization.
• Ensure daily work complies with GMP, data integrity expectations, and Eurofins quality standards.

Required

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmaceutical Sciences, or related field) or equivalent industry experience.
• Experience working within a regulated environment (GMP/GLP/GDP).
• Strong written and verbal communication skills, including the ability to convey technical information clearly.
• Proven attention to detail and strong organizational skills.
• Ability to interpret scientific protocols, quotes, and technical documents.
• Comfortable working with electronic systems such as LIMS or other laboratory informatics tools.

Position is full-time, Mon-Fri 8am-4pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. 

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

 

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.