QC Analyst V, Assay Validation

QC Analyst V, Assay Validation

Job ID: req4072
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 samples, raw materials, and finished products and ensure that they are in compliance with internal and external safety, quality, and regulatory standards.
• Perform periodical analysis of data trends, supporting finished products, in-process samples, and raw materials; recommends corrective actions to Management as necessary.
• Prepares and revises processes for method validation activities.
• Assures compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
• Facilitate, with the Client, the transfer of new or revised methods to Quality Control by preparing supporting documentation, performing complex data analysis, and coordinating laboratory activities.
• Draft method qualification/validation protocols and reports for Management review.
• Design pre-qualification and qualification experiments on bioanalytical methods such as binding assays, HPLC, ELISA, Western blots, and gel electrophoresis.
• Provide on-going assessment of method performance for all qualified methods and provide Management with regular updates.
• Assist with the analytical instrument qualification documentation.
• Participate in method or equipment troubleshooting activities.
• Prepare technical presentations for meetings with Management, the Client, and other external collaborators.
• Interact regularly with QC analysts and Management, in addition to the Government Client.
• Manage the tech transfer progress, including timeline management and assay qualification/tech transfer documentation.
• Build and manage the assay performance trending for assay system suitability, reference standard, and assay control results spread sheet, and manage the documentation.
• Author/review project transfer plans and transfer reports

BASIC QUALIFICATIONS

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

• Possession of Master’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or six (6) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of ten (10) years of progressively responsible job-related experience, including QC experience
  • Experience should include a minimum of three (3) years in a pharmaceutical cGMP environment.
• Must possess basic Microsoft Office skills including Microsoft Project.
• Working knowledge of regulatory guidance’s pertaining to GMP laboratory operations
• Understanding of regulatory guidance for method validation and the ability to assess methods of variable complexity following this guidance.
• Ability to author SOPs, qualification protocols and reports, and complex technical data summaries with minimal oversight
• Ability to perform complex data analysis using statistical tools.
• Demonstrates strong technical writing skills.
• Experience in method validation and equipment qualification.
• Demonstrated experience performing analytical investigation with focus on root cause analysis.
• Experience with method transfer activities.
• Experience with method qualification/validation activities.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Analytical instrument qualification.
• Use of statistical software such as jmp, GraphPad, or other similar systems.
• Experience working in an analytical laboratory.
• Experience with proteins and purified DNA.
• Experience with novel vaccine platforms such as virus-like particles, nanoparticles, and fusion protein.
• Experienced on Microsoft project and with project management.

PHYSICAL REQUIREMENTS

• Ability to wear Personal Protective Equipment (PPE).
• Ability to enter a laboratory or encounter a hazardous area.
• Ability to manage high levels of screentime.

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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