Frederick National Laboratory for Cancer Research

Vaccine Manufacturing Purification Operations Supervisor

Location
Frederick, MD
Posted
Nov 22, 2021
Ref
req2273
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

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

The Vaccine Manufacturing Purification Operations Supervisor:

  • 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
  • Prepares documentation, reports, and standard operating procedures
  • 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
  • Operates advanced buffer/media skid, chromatographic skid equipment, cGMP autoclaves, and basic lab equipment
  • Performs aseptic formulation and filling, controlled rate freezing
  • Performs in-process sampling, formulation of raw materials
  • Performs column packing/unpacking and qualification of columns from 10 cm to 63 cm ID
  • Operates Tangential Flow Filtration (TFF) filters, holders, and systems
  • Performs filter integrity testing

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 scientific or engineering field may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • Minimum of 4 years' experience in a manufacturing environment plus 2 years' manager experience
  • Working knowledge of cGMPs and computer-assisted manufacturing and production equipment
  • Clean room and BL2 experience
  • Skills/experience in processes and equipment associated with column chromatography techniques from small to pilot scale
  • Skills/experience in processes and equipment associated with tangential flow filtration techniques
  • Ability to be gowning certified
  • Ability to lift up to 35 pounds
  • This position may require working on 2nd or 3rd shift and weekends as needed
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Possession of one or more skills in the following areas:

  • Purification experience in contract manufacturing setting is highly desirable
  • Unicorn software experience
  • Skills/experience in processes and equipment associated with depth filtration techniques
  • Ability to interface with Quality Control, Quality Assurance, Materials Management

JOB HAZARDS

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