PROFESSIONAL & TECHNICAL SERVICES, LLC
Full Time, Exempt
***THIS POSITION IS
CONTINGENT UPON CONTRACT AWARD***
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.
(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
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
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.
perform this job successfully, an individual must be able to perform each
essential duty satisfactorily.)
and experience working on similar modeling and simulation projects.
and expertise in quantitative clinical pharmacology and pharmaceutical science.
in in vitro in vivo correlation for understanding critical quality attributes
of complex formulations.
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.
Corporation and family of companies is an EOE.
Employer Minorities/Women/Veterans/Disabled/Sexual Orientation/Gender Identity
preference under PL 93-638.
participate in the E-Verify Employment Verification Program.