Vaccine Manufacturing Fermentation Engineer
Frederick National Laboratory
Frederick, MD

About $67,000 - $99,000 a year

EducationSkills
Job ID: req651
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases.

Position Overview:
PROGRAM DESCRIPTION
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.

KEY ROLES/RESPONSIBILITIES

Participates in bioprocessing scale-up and technology transfer of Upstream processes (microbial and mammalian cultures)
Troubleshoots problems, analyzing situations and data with in-depth evaluation of various factors
Authors and revises documents (MBR’s and SOP’s) for upstream processes and equipment
Performs root cause analysis for deviations, and defines corrective and preventive actions for potential improvements
Provides process and equipment training for manufacturing associates
Provides support for QA and Regulatory for investigations and audits
Reviews documents for regulatory submissions
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria
Support FAT, SAT and validation activities
Evaluate new technology and provide suggestions for improvement of manufacturing processes
Will work with government process development scientists in the performance of assigned duties and will be responsible for ongoing communications to working groups and project teams

BASIC QUALIFICATIONS

Possession of a Bachelor’s degree from an accredited college or university (according to CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
In addition to education requirements, a minimum of five (5) years of progressively responsible job-related experience in a pharmaceutical cGMP environment
Experience in working and troubleshooting of stainless steel and single use bioreactors
Hands-on experience in mammalian and microbial processes and prior experience in process scale-up and tech-transfer
Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Master’s degree in biochemical engineering or related field
Engineering analysis of bioprocessing methods; may include a specialty in downstream purification (e.g., filtration, ultrafiltration, chromatography separations, system programming) or bioreactor cell culture/fermentation (e.g., cell expansion, bioreactor control and analysis, centrifugation and depth filtration for clarification)
Experience in leading cross-functional and departmental meetings
Experience using Rockwell automation software

JOB HAZARDS OR REQUIREMENTS

Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)