QC Bioanalytical Analyst II

Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. and addresses urgent and intractable problems in biomedical sciences, including cancer, AIDS, drug development, nanotechnology in medicine, and emerging infectious diseases.

About the Program

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics for global infectious diseases (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). VCMP operates a pilot plant facility in Frederick, MD, engaged in cGMP manufacture, testing, release, and supply of Phase I/II clinical products for investigational use in the U.S. and globally.

Responsibilities

• Evaluate and implement protocols and methods to inspect and test in-process raw materials and finished products, ensuring compliance with internal and external safety, quality, and regulatory standards.
• Perform analysis and identify trends in the inspection of finished products, in-process materials, and bulk raw materials; recommend corrective actions when necessary.
• Develop processes and tests to ensure appropriate quality control analysis is performed.
• Prepare documentation for inspection and testing procedures.
• Evaluate and analyze efforts in organizing, documenting, and interpreting inspection support documents and records.
• Ensure compliance with in-house and/or external specifications and standards (e.g., GLP, GMP, ISO, Six Sigma).
• Operate laboratory instrumentation, including imaging Capillary Electrophoresis (iCE3), GXII Touch, Octet, and HPLC/UPLC technologies.
• Conduct routine and non-routine analytical analysis of in-process, finished product, and stability samples according to standard operating procedures (SOPs).
• Perform peer review of data to ensure compliance with SOPs, FDA, cGMP, and GLP regulations.
• Follow good documentation practices to ensure appropriate documentation of test results.
• Prepare documentation for testing procedures and perform required data analysis, compiling data and summarizing results for review.
• Oversee laboratory instrumentation calibration and maintenance; troubleshoot method and instrument issues to resolution.
• Participate in internal quarterly quality audits, OOS, non-conformances, trend investigations, and change controls.
• Aid in the revision, review, and drafting of new and existing SOPs.
• Maintain the safety and orderliness of the lab in accordance with 5s principles.
• Plan tasks and activities with supervisor oversight on a weekly basis in accordance with established schedules, group objectives, and priorities.
• Receive, store, and document incoming receipt of samples, test articles, and materials utilized in bioanalytical testing in accordance with cGMP best practices.
• Occasionally require non-regular work hours and weekends to support manufacturing activities.

Requirements

• Bachelor’s degree from an accredited college or university in a related field (Biology, Chemistry, Biochemistry, or related science). Four years of equivalent, directly relevant experience in a cGMP lab environment may substitute for the required education. Foreign degrees must be evaluated for U.S. equivalency.
• Minimum of two years of job-related experience.
• Basic Microsoft Office skills.
• Experience in a cGMP/GLP laboratory.
• Demonstrated working knowledge of basic laboratory skills and techniques (buffer and solution preparation, pH measurement, visual appearance testing, gel electrophoresis, or ELISA), as well as experience with general bioanalytical laboratory equipment including UV-Vis spectrophotometer and multi-detection plate reader.
• Ability to draft, revise, and follow cGMP SOPs related to laboratory instruments and simple test methods, assist with investigations, review data of minimal complexity, and compile simple data analysis and report results.
• Ability to work with assistance on tasks of moderate complexity, demonstrating independent thought and scientific rationale.
• Ability to succeed in a team-oriented environment under instruction of supervisor and/or more senior analysts, operating under dynamic conditions and condensed timelines.
• Detail-oriented with strong organizational and verbal communication skills.
• Basic math skills.
• Ability to obtain and maintain a security clearance.

Preferred Qualifications

• Experience with bioanalytical methodologies such as PCR, Bio-layer Interferometry, Chromatography, or Microfluidic Electrophoresis.
• Use of LIMS, EDMS, ERP, and other electronic systems.

Physical Qualifications

• Ability to maintain balance at all times, walk, hear (corrective appliance allowed), lift/carry up to 50 lbs, reach above shoulders, climb step ladders/step-stools, push/pull, and stand for extended periods.
• Ability to wear Personal Protective Equipment (PPE).
• Capable of working in a laboratory with potentially hazardous chemicals.
• Ability to operate equipment that uses compressed or liquid gas.
• Visual acuity to include depth perception and vision correctable to 20/40.
• Pacemaker prohibited.

Job Hazards

This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.

Pay

57,700.00 - 82,711.00 USD. The posted pay range is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include responsibilities of the job, education, experience, knowledge, skills, abilities, internal equity, and alignment with market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part-time positions.

Benefits

Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave, and Retirement.