QC Bioanalytical Analyst

QC Bioanalytical Analyst

Job ID: req4097
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

• 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 standards 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 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 plans 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.

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 five (5) years of progressively responsible 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, gel electrophoresis and 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 and medium complexity, denoting and reporting any abnormalities, as well as compile data analysis and report results.
• Ability to work mostly unassisted on tasks of moderate complexity, demonstrating independent thought and scientific rationale.
• Ability to obtain and maintain a security clearance.

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.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Some experience with Bioanalytical methodology including Octet, HPLC, Microfluidic Electrophoresis
• Use of LIMS, EDMS, ERP, and other electronic systems.
• Ability to succeed in a team-oriented environment, operating under dynamic conditions and condensed timelines.
• Detail oriented with strong organizational and verbal communication skills.

JOB HAZARDS

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

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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