Biomedical/Chemical Engineer - FDA

Chenega Corporation
US-MD-Silver Spring
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  • Post Date: Apr 15, 2019
  • Start Date: 4/15/2019
  • Job Type: Full-Time

Job Description

CHENEGA PROFESSIONAL & TECHNICAL SERVICES, LLC

 

Company Job Title:

Biomedical/Chemical Engineer–FDA-ORS

Chenega Job Title:

  Clearance:

Public Trust

Location:

Silver Spring, MD

Reports To:

Program Manager

FLSA Status:

Regular, Full Time, Exempt

Prepared Date:

3-27-2019

Approved Date:

3-27-2019    

***THIS POSITION IS CONTINGENT UPON CONTRACT AWARD***

  Summary:

Chenega Professional and Technical Services, LLC (CPTS) is seeking a Biomedical/Chemical Engineer to support the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Research and Standards (ORS), Division of Quantitative Methods and Modeling (DQMM).  The Biomedical/Chemical Engineer shall provide database development and modeling and simulation support for all the quantitative modeling research projects managed by OGD.  This individual will provide expertise on the mechanistic principles governing drug delivery from both a formulation perspective and from a physiological perspective for the purposes of developing new bioequivalence methodologies and tools.

 

Duties and Responsibilities: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position)

  • Compile a large database incorporating data from new drugs and generic drugs on physiochemical characterization, in vitro dissolution, in vivo PK and in vivo therapeutic effect for assigned products.

  • Develop new mechanistic modeling on in vitro/in vivo correlation and physiologically based PK modeling methodologies.

  • Perform simulations to address issues related to BE evaluation such as setting up bio-predictive dissolution methods and improving upon current PBPK models for PK prediction following oral route of drug administration.

  • Use model-based approaches to address regulatory questions as arise from citizen petitions, (abbreviated new drug application) pre-ANDA meeting requests, ANDA review consults, and product specific guidance development.

  • Connect and engage with stakeholders from Office of Bioequivalence, Office of Clinical Pharmacology, Office of Product Quality, and Office of New Drugs to identify new research questions and establish new research projects.

  • Attend mission critical conferences and get updates on latest development of modeling techniques.

  • Wrap up work in the forms of reviews, posters, scientific presentations, and publications.

  • Mentor junior modelers and scientists.
  • Other duties as assigned.
 

Minimum Qualifications: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)

  • Bachelor’s degree and preferred 8 years of relevant experience.

  • Experience developing bioequivalence methods and tools.

 

Knowledge, Skills and Abilities:

  • Knowledge and experience working on similar modeling and simulation projects.

  • Knowledge and expertise in quantitative clinical pharmacology and pharmaceutical science.

  • Expertise in in vitro in vivo correlation for understanding critical quality attributes of complex formulations.

  • Experience in dataset construction, model development and trial simulation.

 

Physical Demands: (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

  • While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.

 

Work Environment: (The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.)

  • The employee will normally work in a temperature-controlled office environment, with frequent exposure to electronic office equipment.

  • During visits to areas of operations, may be exposed to extreme cold or hot weather conditions.  Is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and loud noise.

 

Chenega Corporation and family of companies is an EOE.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity

Native preference under PL 93-638.

We participate in the E-Verify Employment Verification Program.

M#





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