Stability Protocol Writer

Eurofins Lancaster Laboratories is seeking a detailoriented 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 Eurofinsgenerated quotes into accurate compliant protocols and complete study builds within the LIMS system.

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

Key Responsibilities

• Translate Eurofinsgenerated quotes into fully developed compliant stability protocols within the LIMS system.
• Build stability studies based on clientprovided 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.

Qualifications :

Required

• Bachelors 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.

Additional Information :

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.

Remote Work :

No

Employment Type :

Full-time