Offer summary

Qualifications:

Bachelor's degree in microbiology, biochemistry, or related life sciences; advanced degree preferred., Minimum of 5 years of GMP pharmaceutical or biologics manufacturing experience, focusing on endotoxin control and testing., Expertise in cell and gene therapy environments with proven problem-solving skills for endotoxin issues., Strong knowledge of regulatory guidelines such as USP, FDA, EMA, and ICH..

Key responsibilities:

Serve as the on-site expert for endotoxin-related issues and troubleshooting.

Provide guidance on endotoxin testing methods and process optimization.

Support sampling, validation, and compliance activities related to endotoxin limits.

Collaborate with teams to evaluate risks, implement control strategies, and prepare for audits.

Job description

This is a six-month contract position with no benefits.
Position Overview
We are seeking a highly skilled Endotoxin Specialist with deep expertise in endotoxin control, detection, and remediation within a GMP-compliant cell and gene therapy manufacturing environment. This position combines strategic advisement with on-site, hands-on execution. The specialist will support quality control, manufacturing, quality assurance, and technical operations by applying advanced knowledge of endotoxins to improve processes, resolve issues, and drive compliance. Experience supporting fill-finish operations in this environment is a strong plus.

Responsibilities

*Serve as the on-site subject matter expert for all endotoxin-related issues, including low endotoxin recovery, deviation support, and contamination prevention

*Provide expert guidance on the application, interpretation, and optimization of LAL and alternative endotoxin testing methods such as recombinant Factor C

*Support sampling strategies, hold time studies, in-process controls, and cleaning validations to ensure compliance with endotoxin limits

*Partner with manufacturing and quality teams to evaluate raw material risks, assess vendor controls, and implement robust endotoxin control strategies across the supply chain

*Participate directly in real-time troubleshooting, contamination response, environmental monitoring review, and deviation investigations

*Author and review protocols, technical reports, risk assessments, SOPs, and training content in accordance with applicable regulatory standards including USP, FDA, EMA, and ICH

*Advise on inspection readiness and participate in audit preparation and response related to endotoxin or pyrogenic concerns

*Train site teams on best practices related to cleanroom behaviors, aseptic techniques, and contamination control

Qualifications

*Bachelor’s degree in microbiology, biochemistry, or a related life sciences discipline. An advanced degree is preferred

*A minimum of 5 years of experience in GMP pharmaceutical or biologics manufacturing, with a strong focus on endotoxin control and testing

*Expertise in cell and gene therapy environments is required, with demonstrated success solving complex endotoxin-related issues

*Hands-on experience with aseptic processing and support of fill-finish operations in regulated settings is highly desirable

*Strong understanding of USP <85>, <1085>, FDA, EMA, and ICH guidelines relevant to endotoxin testing and control

*Excellent technical writing, communication, and cross-functional collaboration skills

*Ability to work independently and contribute effectively as an embedded expert in a dynamic and fast-paced production setting

This is a remote position that requires some on-site presence in Massachusetts

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