QC Bioanalytical Analyst II

Employee Type: exempt full-time | Division: Vaccine Clinical Materials Program | Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

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 to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick, MD-based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I/II clinical products for investigational use in the U.S. and globally.

Responsibilities

• Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products to ensure compliance with internal and external safety, quality, and regulatory standards for distribution.
• Performs analysis and identifies trends in the inspection of finished products, in-process materials, and bulk raw materials, recommending corrective actions when necessary.
• Develops processes and tests to determine appropriate quality control analysis is being performed.
• Prepares documentation for inspection and testing procedures.
• Evaluates and analyzes efforts in organizing, documenting, and interpreting inspection support documents and records.
• Ensures compliance with in-house and/or external specifications and standards (e.g., GLP, GMP, ISO, Six Sigma).
• Operates basic laboratory instrumentation and more complex equipment such as imaging Capillary Electrophoresis (iCE3), GXII Touch, Octet, and HPLC/UPLC technologies.
• Conducts routine and non-routine analytical analysis of in-process, finished product, and stability samples according to standard operating procedures (SOPs).
• Performs peer review of data to ensure compliance with SOPs, FDA, cGMP, and GLP regulations.
• Follows good documentation practices to ensure appropriate documentation of test results.
• Performs required data analysis, compiles data, and summarizes results for review.
• Oversees laboratory instrumentation calibration and maintenance.
• Troubleshoots method and instrument issues to resolution.
• Participates in internal quarterly quality audits.
• Participates in OOS, non-conformances, trend investigations, and change controls.
• Aids in the revision, review, and drafting of new and existing SOPs.
• Maintains the safety and orderliness of the lab in accordance with 5s principles.
• Plans tasks and activities with supervisor oversight on a weekly basis in accordance with established schedules, group objectives, and priorities.
• Receives, stores, and documents incoming receipt of samples, test articles, and materials utilized in bioanalytical testing in accordance with cGMP best practices.
• Occasionally requires non-regular work hours and weekends to support manufacturing activities.

Requirements

• Possession of a 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.
• Ability to perform basic math skills.
• Ability to obtain and maintain a security clearance.

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.

Preferred Qualifications

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

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

Benefits

Pay and benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave, and Retirement. More details are available on the Leidos website.