Frederick National Laboratory QC Bioanalytical Analyst Vacancy
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.
Job Title: QC Bioanalytical Analyst
Location: Frederick, MD, United States
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 Chemistry or Biology (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, must have five (5) years of experience.
- Must possess basic Microsoft Office skills.
- Experience in a biopharmaceutical cGMP laboratory.
- 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.
- 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.
- Ability to obtain and maintain a security clearance.
Candidates with these desired skills will be given preferential consideration:
- Some experience with Bioanalytical methodology including PCR, ELISA, Electrophoresis.
- Use of LIMS, EDMS, ERP, and other electronic systems.
- Ability to work mostly unassisted on tasks of moderate complexity, demonstrating independent thought and scientific rationale.
- Ability to succeed in a team-oriented environment, operating under dynamic conditions and condensed timelines.
- Detail oriented with strong organizational and verbal communication skills.
This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.
- Develops processes and tests to determine that appropriate quality control analysis is being performed.
- 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.
- 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 (GDP) 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.
- Independently plan routine tasks and activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities.
- 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.
- Participate in analytical method transfer and assay qualification.
Occasionally require non-regular work hours and weekends as needed to support manufacturing activities.
Frederick National Laboratory
Frederick National Laboratory QC