Supervisor, Vaccine Manufacturing Filling Operations

Job ID: req3334
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

• Oversees and directs the development, planning, implementation and maintenance of manufacturing methods, processes, and operations for new or existing products and technologies.
• Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times.
• Prepares documentation, reports and standard operating procedures as required.
• Ensures the effective use of materials, equipment, and employees in producing quality products.
• May monitor and control labor and capital expenditures.
• Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
• Perform and schedule drug product component preparation.
• Perform and schedule aseptic formulation and filling.
• Perform and schedule vial inspection and labeling activities under current Good Manufacturing Practices (cGMPs).
• Interface with Quality Control/Quality Assurance, Facility groups, and outside equipment vendor groups.
• Draft deviations and change controls.
• Interact with customers and/or senior management.

BASIC QUALIFICATIONS

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 a scientific or engineering discipline (Qualifying experience (4 years) in a scientific or engineering field may be substituted for the required education).
• Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of four (4) years’ experience in a manufacturing environment plus two (2) years’ supervisory experience.
• Knowledge of cGMP operations, cleanroom environment, and aseptic pharmaceutical filling.
• Knowledge of the regulatory issues associated with cGMP manufacturing of biopharmaceutical products.
• Knowledge of cGMPs as they relate to manufacturing operations.
• Working knowledge of computer assisted manufacturing/production equipment.
• Ability to lift up to 35 pounds.
• Ability to work in a BL2 environment.
• This position may require working on 2nd or 3rd shift and weekends as needed.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience in barrier isolator technology.
• Experience in lyophilization.

JOB HAZARDS

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

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