QC Bioanalytical Analyst IV in Frederick, MD

Description

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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

• Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standard requirements for distribution.
• Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary.
• Develops processes and tests to determine that appropriate quality control analysis is being performed.
• Prepares documentation for inspection/testing procedures.
• Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records.
• 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) GXII Touch, Octet Potency, and HPLC/UPLC technologies.
• Conduct routine and non-routine analysis of in-process, finished product, and stability samples according to Standard Operating Procedures (SOPs).
• Ensure compliance with SOPs, FDA, cGMP and GLP regulations.
• Follow good documentation practices to ensure appropriate documentation of test results.
• Develop and/or optimize analytical test methods.
• Perform required data analysis, review complex data, interpret data findings, investigate issues and report abnormalities, troubleshoots analytical methods.
• Prepare and submit data summaries of advanced complexity for review.
• Perform routine maintenance and troubleshoot instrument and method issues through resolution.
• Receive, store, aliquot and document incoming receipt of samples, test articles, and materials utilized in bioanalytical testing and in accordance with cGMP best practices.
• Participate in out-of-specification (OOS) investigations, non-conformances, trend investigations, change controls and corrective and preventative actions (CAPA).
• Draft and revise SOPs.
• Maintain the safety and orderliness of the lab.
• Perform method transfer and qualification activities.
• Communicate and coordinate with counterparties to address methodology questions and data findings.
• Participate and present data findings to the department and outside parties.
• Use your experience of assay and experimental design to support delivery of robust bioanalytical data. Occasionally require non-regular work hours and weekends as needed to support manufacturing activities.
• Coordinate and schedule instrumentation IQ/OQ, PM and repairs with vendors.

BASIC QUALIFICATIONS

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

• Possession of Bachelor's degree in Biology or Chemistry from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in a cGMP lab environment in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of eight (8) years of experience.
• Must possess basic Microsoft Office skills.
• Use of LIMS, EDMS, ERP and other electronic systems.
• Demonstrated working knowledge of basic laboratory skills and techniques (buffer and solution preparation, pH measurement, visual appearance testing, gel electrophoresis and ELISA), as well as experience with general Bioanalytical laboratory equipment including UV-Vis spectrophotometer, liquid chromatographs and multi-detection plate reader.
• Experience with Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (cGMPs)
• Ability to follow SOPs of simple to complex technical content and comply with cGMPs/GLPs
• Experience with general analytical laboratory techniques, and specific techniques such as chromatography, PCR, ELISA, or electrophoresis (one technique minimum).
• Ability to guide and train team members and serve as the subject matter expert in physicochemical and biological assays.
• This position is considered a safety-sensitive position and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience with and/or knowledge of method qualification/validation, protein analysis, and DNA analysis.
• Strong background in implementing phase-appropriate assays for various analytical methods such as SEC, RP-HPLC
• Ability to work mostly unassisted on tasks of moderate complexity, demonstrating independent thought and scientific rationale. HILIC, IEX, CE-SDS, cIEF as well as ELISA and qPCR
• Proven ability to work successfully in cross-functional teams and represent at various internal and external meetings.
• Ability to succeed in a team-oriented environment, operating under dynamic conditions and condensed timelines.
• Detail oriented with strong organizational and verbal communication skills.

PHYSICAL QUALIFICATIONS

• Physical requirements include the ability to maintain balance at all times, walk, hear (corrective appliance allowed), lift/carry up to 25lb, 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 and/or service 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 have potential for exposure to infectious material, requiring medical clearance and immunizations.