Senior QC Scientist - ASAT
Job Locations US-MD-Silver Spring
# of Openings 1
Category WRAIR PBF
Type Regular Full-Time
Min USD $101,383.00/Yr.
Max USD $124,846.00/Yr.
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.
• Exceptional multitasking, project management, and communication skills, with a proactive, results-driven 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 www.CAMRIS.com. 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 long-term 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 tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.
Employment is contingent upon the successful completion of a Public Trust-level 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.
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