QC Bioanalytical Analyst II

Job ID: req2838
Employee Type: exempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

THIS POSITION OFFERS FLEXIBILITY INCLUDING SOME TELEWORK/HYBRID WORK.

PROGRAM DESCRIPTION

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 US and globally.

KEY ROLES/RESPONSIBILITIES

Reporting to the QC Bioanalytical Supervisor, the QC Analyst II will:

• Operate basic laboratory instrumentation and that of more medium or complex nature such as (but not limited to) imaging Capillary Electrophoresis (iCE3), GXII Touch, 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.
• Prepare documentation for testing procedures.
• Follow good documentation practices to ensure appropriate documentation of test results.
• Perform required data analysis, compile data, and summarize results for review.
• Oversee laboratory instrumentation calibration and maintenance.
• Troubleshoot method and instrument issues to resolution.
• Participate in internal quarterly quality audits.
• Participate in 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 and in accordance with group objectives and priorities.
• Receive, store, and document incoming receipt of samples, test articles, and materials utilized in bioanalytical testing and in accordance with cGMP best practices.
• Occasionally require non-regular work hours and weekends as needed to support manufacturing activities.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in Science (Chemistry, Biology, Biochemistry, or related science), (Qualifying four (4) years equivalent, directly relevant, experience in a cGMP lab environment may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of two (2) years of job-related experience.
• Experience in a biopharmaceutical cGMP laboratory.
• Demonstrated working knowledge of basic laboratory skills and general Bioanalytical laboratory equipment including spectroscopy, pH, and appearance testing.
• 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 obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience with basic laboratory techniques including buffer and solution preparation, pH measurement, and spectroscopy.
• Some experience with Bioanalytical methodology including PCR, ELISA, Electrophoresis, Spectrophotometry, UPLC/HPLC.
• Detail oriented with strong organizational and verbal communication skills.
• Ability to succeed in a team-oriented environment, operating under dynamic conditions and condensed timelines.
• Use of LIMS, EDMS, ERP, and other electronic systems.
• Strong attention to detail, organized, good laboratory steward.

JOB HAZARDS

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

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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