Senior QC Scientist - ASAT

Overview

We are seeking a Senior Quality Control Scientist - Analytical Sciences and Technology (ASAT) to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

 

PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.  

 

CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. 

 

Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

 

Responsibilities

• Serve as a technical leader in the QC Analytical Sciences and Technology team, providing expert-level support in technical writing, process optimization, QC sampling strategies, equipment lifecycle management, and LIMS oversight.
• Design, plan, and oversee the execution of complex analytical testing for drug development, including leading method transfers to CDMOs and ensuring alignment with project goals and regulatory expectations.
• Lead cross-functional method transfer initiatives, ensuring timely and effective knowledge and technology transfer.
• Interpret analytical data with high scientific rigor, author technical reports, and provide strategic insights for decision-making.
• Lead the drafting and review of method transfer and validation protocols, reports, and SOPs in compliance with regulatory standards.
• Oversee equipment qualification (IQ/OQ/PQ), calibration, and maintenance to ensure optimal lab performance and readiness.
• Monitor and coordinate testing activities for starting materials, drug substances, and drug products activities conducted at PBF.
• Provide strategic oversight for method development and validation to ensure methods are scientifically sound, robust, and phase-appropriate.
• Review and approve analytical results and supporting documentation to ensure quality standards are met for release and stability testing of starting materials, drug substances, and drug products.
• Drive data trend analysis for stability programs and proactively identify potential quality or performance issues.
• Support complex analytical characterization activities, such as identifying novel degradation products or impurities.
• Develop and manage project plans and timelines.
• Lead the management and qualification of reference standards and critical reagents.
• Support LIMS development and implementation.
• Collaborate with the Quality Assurance team to ensure a compliant, inspection-ready state.
• Review technology transfer documentation with regulatory and appropriate groups and provide scientific guidance.
• Mentor and train junior scientists and contribute to team development and knowledge sharing.
• Conduct ASAT cross-training and performance of viral testing methods as required.
• Performs other related duties as assigned.

Qualifications

• A master's degree and 10 years of pharma industry analytical experience working within analytical development/validation or an equivalent combination of education and credentials. A PhD is highly preferred.
• Demonstrated leadership in analytical method development, qualification, and transfer within GMP environments.
• Expertise in Quant Studio 5/7, mRNA characterization, method qualification, in-process testing, and stability testing.
• Extensive hands-on experience with PCR, UPLC, LC-MS, and ELISA.
• Proven success working in or managing analytical projects involving external CDMOs or contract labs.
• Proficiency with LIMS platforms (preferably LabVantage), and experience leading LIMS-related improvements or implementations.
• Strong knowledge of cGMPs/GLPs, ICH, FDA, and CMC regulatory guidance, with demonstrated experience in regulatory submissions.
• Strong preference for a scientist with CGE/cIEF experience. 
• Experience with microbiological assays is a plus.
• Ability to lead, develop, and mentor scientific staff as required.