Endotoxin Expert
Endotoxin Expert
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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
*Bachelors 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 @. If you receive a message that seems suspicious or is not from our official domain please report it immediately to
Required Experience:
Senior IC
Employment Type
Full-Time
