Fill/Finish Process Engineer (NCI) - Frederick, MD | Biospace
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Fill/Finish Process Engineer (NCI)

Leidos Biomedical Research, Inc.

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Location:
Frederick, MD
Posted Date:
10/19/2016
Position Type:
Full time
Job Code:
632478
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Operations, Formulation, Vaccine,

Job Description

COMPANY INFORMATION
Leidos Biomedical Research, Inc. (LBRI), a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research (FNLCR). FNLCR is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). It is the only FFRDC dedicated to biomedical research. Through its status as an FFRDC, FNLCR provides NCI and others with a unique national resource to accelerate the development and delivery of effective preventive, diagnostic, and therapeutic products for cancer and AIDS.

The breadth of FNLCR’s activities spans the research and development spectrum, including investigator-initiated, hypothesis-driven research into cancer and AIDS; advanced technology programs focused on genetics and genomics, proteins and proteomics, imaging, nanotechnology, bioinformatics, and laboratory animal sciences; clinical operations in support of NCI and National Institute of Allergy and Infectious Diseases (NIAID)-sponsored clinical trials, as well as NCI drug discovery and development efforts; and management and operations of biopharmaceutical development and manufacturing programs under current Good Manufacturing Practice conditions for NCI and NIAID. Administrative, procurement, financial, safety, and facilities support is provided to these R&D activities through state-of-the-art business processes.  LBRI has approximately 1,900 employees and manages an annual operating budget of approximately $450M.

For more information about Leidos Biomedical Research Inc., please visit our webpage at www.leidosbiomed.com.

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.

JOB DESCRIPTION
Reporting to the Director of Manufacturing Operations, the Process Engineer: 1) assists in formulation/solution scale up, technology transfer and troubleshooting formulation/solution and/or filling process problems, where analysis of situations and of data requires in-depth evaluation of various factors, 2) exercises judgment within broadly defined practices and policies in developing formulation methods for aseptic drug products, techniques and evaluation criteria for troubleshooting investigations, 3) may determine processing methods and procedures on new technology transfer assignments and may provide guidance to other lower level personnel, 4) serves as POC for formulation/fill and solution tech transfer activities, working directly with government process development scientists in the performance of assigned duties, and 5) will be responsible for translating acquired information into process specifications and batch production records and ongoing communications with working groups and project teams.

Requirements

BASIC QUALIFICATIONS
Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in biochemical engineering or a related field or four (4) years of related experience in lieu of degree
Foreign degrees must be evaluated for U.S. equivalency
Minimum of five (5) years of progressively responsible job related experience in formulation development, solution/buffer preparation or formulation scale-up in a pharmaceutical cGMP manufacturing environment that includes automated filling operations
Experience with equipment associated with solution preparation and analysis (i.e. buffer preparation skids, pH/conductivity meters, osmometers, viscometers/viscosity meter)
PREFERRED QUALIFICATIONS
Master’s degree in biochemical engineering or related field
Experience in engineering analysis of bioprocessing methods; may include a specialty in formulation development, solution/buffer preparation (e.g., filtration, lyophilized product formulation, chromatography separations), formulation/fill scale-up (lyophilizer cycle development/ troubleshooting), or barrier isolator filling technology.
Familiarity with assays and test methods used to evaluate solution characteristics (e.g. conductivity, viscosity, osmolarity, pH)