Qc Bioanalytical Analyst Jobs

QC Bioanalytical Analyst

Job ID: req3468
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.

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

• Participate in internal quarterly quality audits.
• Maintain the safety and orderliness of the lab in accordance with 5s principles.
• Perform required data analysis, compile data, and summarize results for review.
• Independently plan routine tasks and activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities.
• Oversee laboratory instrumentation calibration and maintenance.
• Occasionally require non-regular work hours and weekends as needed to support manufacturing activities.
• Troubleshoot method and instrument issues to resolution.
• Prepare documentation for testing procedures.
• May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
• Operate basic laboratory instrumentation and that of more medium or complex nature such as (but not limited to) imaging Capillary Electrophoresis (iCE3), GXII Touch, ELISA, Octet Potency, and HPLC/UPLC technologies.
• Participate in OOS, non-conformances, trend investigations and change controls.
• Follow good documentation practices (GDP) to ensure appropriate documentation of test results.
• Conduct routine and non-routine analytical analysis of in-process, finished product, and stability samples according to standard operating procedures (SOPs).
• Provide guidance to peers or lower-level personnel/team members
• Receive, store, and document incoming receipt of samples, test articles, and materials utilized in bioanalytical testing and in accordance with cGMP best practices.
• Aid in the revision, review, and drafting of new and existing SOPs.
• Perform peer review of data to ensure compliance with SOPs, FDA, cGMP and GLP regulations.
• Develops processes and tests to determine that appropriate quality control analysis is being performed.
• Participate in analytical method transfer and assay qualification.

BASIC QUALIFICATIONS

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

• In addition to the education requirement, must have five (5) years of experience.
• Ability to draft, revise, and follow cGMP SOPs related to laboratory instruments and simple test methods, assist with investigations, review data of minimal and medium complexity, denoting and reporting any abnormalities, as well as compile data analysis and report results.
• Foreign degrees must be evaluated for U.S. equivalency.
• Demonstrated working knowledge of basic laboratory skills and techniques (buffer and solution preparation, pH measurement, visual appearance testing), as well as experience with general Bioanalytical laboratory equipment including spectroscopy, and UPLC/HPLC.
• Must possess basic Microsoft Office skills.
• Ability to obtain and maintain a security clearance.
• Experience in a biopharmaceutical cGMP laboratory.
• Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in Chemistry or Biology (Qualifying four (4) years equivalent, directly relevant, experience in a cGMP lab environment may be substituted for the required education).

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Detail oriented with strong organizational and verbal communication skills.
• Some experience with Bioanalytical methodology including PCR, ELISA, Electrophoresis.
• Ability to succeed in a team-oriented environment, operating under dynamic conditions and condensed timelines.
• Ability to work mostly unassisted on tasks of moderate complexity, demonstrating independent thought and scientific rationale.
• Use of LIMS, EDMS, ERP, and other electronic systems.

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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