Bioengineer V - Clearance Required

Overview

LMI is seeking a qualified Bioengineer V to support our Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS) client at our Ft. Detrick, MD location. This position requires an active Secret clearance or be eligible to obtain a Secret clearance. You must be a U.S. citizen.

LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers' unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.

LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!

Responsibilities

• Provide input to project planning and execution and provide input to risk mitigation precautions.
• Analyze and provide input to possible risk to cost schedule and performance in the development effort.
• Analyze plans and provide risk mitigation input to potential risk to cost, schedule and performance for the GMP manufacturing processes development, scale-up, technical transfer, and validation stages of the project.
• Provide input to the team to establish a compliant Quality Management System (QMS) with an operational quality unit (Quality Assurance & Quality Control units) to support cGMP manufacturing operations, including device development.
• Provide input to project schedule, cost estimation and budget management.
• Provide input to autoinjector Integrated Product Team (IPT) meetings as follows:
• Monitor and report on the standards employed by autoinjector manufacturers and how the standards are employed in the development or production of auto-injectors.
• Prepare reports to evaluate the use and completion of risk assessment and problem-solving techniques by companies developing auto-injectors.
• Provide input and assist in the development of regulatory strategies, target product profiles, and other regulatory documents related to the design, manufacture, and assembly of the device, obtaining input from subject matter experts as needed.
• Review regulatory strategies related to technical manufacturing for accuracy and consistency.
• Evaluate DoD acquisition documents that include FDA regulatory requirements or impact the drug development timeline.
• Review and provide written feedback on technical records generated during the development process for accuracy and adequacy.
• Evaluate change control documentation to determine product impact
• Serve as a subject matter expert to provide services necessary to evaluate manufacturing processes and review deliverables to assist in the development of auto-injector products, including associated Food and Drug Administration (FDA) regulated activities.
• Provide medical device expertise in reviewing design control documentation, regulatory device documentation, evaluating design team performance and evaluating engineering systems input and output for device manufacture and development.

Qualifications

• PhD in Molecular Biology, Biochemistry, Microbiology, or Biochemical Engineering with extensive knowledge of Virology or Vaccinology, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
• Tradeoff Requirement: Master's degree in Molecular Biology, Biochemistry, Microbiology, or Biochemical Engineering with extensive knowledge of Virology or Vaccinology, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
• Expert with in-depth knowledge of combination products, specifically auto-injector manufacturing, and development, to include the following:

Device Development

Design for Six Sigma

Device reliability

Engineering design and drawings

Manufacturing process development

Component development - molding processes

Cartridge fill/finish and primary container closure systems

• Expert working knowledge of Design History Files, inclusive of legacy products being updated to current Good Manufacturing Practice (GMP) standards, as demonstrated in both previous experience and training courses.
• Expert familiarity and experience evaluating manufacturing processes using all International Standards Organization (ISO) and American Society for Testing and Materials (ASTM) standards related to combination products (e.g., ISO standards 7886-1, 10993-1, 11608 (all parts), 10993-1, 13485, and 14971; ASTM D4169; etc.).
• Expert familiarity with FDA guidance for industry (e.g., "Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products"; Class II devices under 21 Code of Federal Regulations (CFR) 880.5860 < tel:880.5860 > and 21 CFR 880.6920 < tel:880.6920 >; etc.).
• Expert with experience evaluating feedback and preparing submissions for the FDA review centers involved in the approval of combination products, particularly the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH).
• Have experience with relevant risk assessment and problem-solving techniques (e.g., Failure Mode Effects Analysis (FMEA), fault trees, root cause analyses, etc.).
• Active Secret clearance or Secret clearance eligibility. You must be a U.S. citizen.

Target salary range: $114,444 - $201,960

Disclaimer:

The salary range displayed represents the typical salary range for this position and is not a guarantee of compensation. Individual salaries are determined by various factors including, but not limited to location, internal equity, business considerations, client contract requirements, and candidate qualifications, such as education, experience, skills, and security clearances.