Endotoxin Expert
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
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.