QC Associate Director - Bioanalytical in Frederick, MD

Description

QC Associate Director - Bioanalytical

Job ID: req1539
Employee Type: exempt full-time
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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest.  

 Position Overview:

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 other bio-therapeutics to address infectious diseases of global significance (HIV-AIDS, Influenza, Ebola, Zika, Malaria and Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility engaged in GMP manufacture, testing, release and supply of Phase I /II clinical products for investigational use in the US and worldwide.

KEY ROLES/RESPONSIBILITIES

• Manage 14 staff, including 3 supervisors in the Analytical Methods Transfer/Qualification, Bioanalytical Release/Stability, and Raw Material testing groups
• Oversee the bioanalytical testing labs to support in-process, release and stability testing of drug substances and products
• Review data to compliance with established specifications
• Generate product specifications, create sample tables, and CoAs
• Lead laboratory investigations, deviation closure, and CAPA management
• Participate in third party audits
• Perform risk assessments for QC procedures and participate in collaborative risk assessment teams
• Manage third-party testing and result review
• Ensure assay performance by applying appropriate statistical trend analysis
• Ensure the appropriate GMP guidelines are met, implemented and maintained
• Responsible for the generation of data summary reports
• Facilitate the incoming transfer of new assays from the client or other third party
• Facilitate the qualification execution of new or updated assays
• Identify labor hours, material costs, and other resources needed to facilitate project budgets

BASIC QUALIFICATIONS

• Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/scientific discipline or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirements, a minimum of eight (8) years experience in a pharmaceutical or biotech environment
• Six (6) years of experience in a managerial role
• Extensive biotechnology field knowledge in analytical, biochemical and immunological testing
• Ability to implement a rigorous testing program with appropriate operating procedures and cGMP compliance
• Experience in data evaluation, trending and troubleshooting
• Strong proficiency with investigational skills for root cause analysis;
• Ability to lead technical investigations
• Knowledge of the USP, ICH and FDA guidelines related to product testing
• Proficiency with assay methodologies including ligand-binding assays (e.g. ELISA, Western Blot, Octet), Microfluidic electrophoresis, PCR, spectrophotometry, bioassays, and liquid chromatography
• Experience with DNA and protein technologies
• Excellent technical writing skills
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Master's degree
• Experience with methods qualification/validation
• Experience with monoclonal antibodies and recombinant protein technology platforms

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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