Senior QC Scientist - ASAT

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 oneofakind cGMPcompliant pharmaceutical manufacturing facility engaging in nextgeneration development for cuttingedge 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 highquality costeffective programs and research management services. We combine our proven systems with todays most effective evidencebased 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.

• Serve as a technical leader in the QC Analytical Sciences and Technology team providing expertlevel 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 crossfunctional 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 decisionmaking.
• 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 phaseappropriate.
• 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 inspectionready 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 crosstraining and performance of viral testing methods as required.
• Performs other related duties as assigned.

• A masters 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 highlypreferred.
• Demonstrated leadership in analytical method development qualification and transfer within GMP environments.
• Expertise in Quant Studio 5/7 mRNA characterization method qualification inprocess testing and stability testing.
• Extensive handson experience with PCR UPLC LCMS 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 LIMSrelated 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.
• Exceptional multitasking project management and communication skills with a proactive resultsdriven mindset.

Physical Requirements Workplace Hazards and Conditions and PPE and Chemical Requirements

The physical requirements workplace hazards and conditions and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.

Physical Demands

• Constantly conduct sedentary work that primarily involves sitting/standing.
• Constantly conduct light work that includes moving objects up to 20 pounds.
• Occasionally push or pull less than 25 pounds.
• Occasionally reach above shoulder level.
• Constantly use both hands.
• Occasionally stand or walk for more than 25 minutes.
• Occasionally bend reach or twist repeatedly.
• Occasionally kneel squat or stoop.
• Constantly have clear vision (near and/or far) depth perception peripheral vision and/or visual acuity.

Physical Activities

• Occasionally move about to accomplish tasks or move from one worksite to another.
• Constantly communicate with others to exchange information.
• Constantly assess the accuracy neatness and thoroughness of the work assigned.

PPE and Chemical Requirements

• Constantly wear PPE including but not limited to gloves face shields/goggles safety glasses and safety shoes.
• Constantly wear a lab coat.
• Occasionally wear a disposable dust/surgical mask.
• Occasionally come in contact with chemicals such as aerosols biological inhalants plastics inorganic dust and powders etc.

Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin age protected veteran status disability status or any other characteristic protected by any applicable federal state or local law.

CAMRIS offers a comprehensive benefits package including medical dental and vision insurance for individuals and families FSAs HSA life and AD&D insurance short and longterm disability legal services voluntary hospital indemnity critical illness and accident insurances EAP pet insurance 401(k) with employer match and Roth option tuition and professional reimbursement public transportation support in the DMV area a referral bonus program vacation with tenurebased increases PTO 11 paid holidays paid bonding leave and paid supplemental shortterm disability.

Employment is contingent upon the successful completion of a Public Trustlevel background check a requirement for this position under an active federal contract. The background check process may include but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment education and credentials; (3) a criminal background check; (4) use/abuse of federally controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully complete any required background check questionnaire during initial onboarding.