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Scientist III - Research Analyst Mid

Kikiktagruk Inupiat Corporation
Silver Spring, MD
  • Posted: over a month ago
  • Full-Time
Job Description

Title: Scientist III - Research Analyst Mid

Location: Silver Spring, MD

Status: Full-Time

Position Summary:

This position is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Testing and Research (OTR), Division of Product Quality Research (DPQR) at White Oak (WO). OPQ is an umbrella organization overseeing the activities of the Chemistry, Manufacturing, and Controls (CMC) review process and drug testing and scientific evaluation of drug products in support of the regulatory components of FDA. This includes assessment of product and process designed, evaluation of product quality in light of established standards and setting and maintaining new quality standards.

DPQR conducts regulatory research on continuous manufacturing as part of an interdisciplinary research approach to address emerging product quality issues. DPQR is doing research on continuous drug substance manufacturing to address regulatory challenges faced by the Agency for this innovative technology.


  • Collaborates with DPQR staff to identify appropriate PAT equipment and methods based on expertise to advance product quality research goals including writing research proposals and protocols
  • Collaborates with DPQR staff to identify prospective applications for PAT implementation, model development, and validation
  • Develops and validates PAT models to predict manufacturing process performance and/or product quality attributes
  • Documents and communicates research results generated from studies including writing technical reports and scientific papers, as well as delivering oral and poster presentations
  • Works with DPQR management to coordinate activities for the PAT group within DPQR
  • Works with DPQR management to establish collaborations with other PAT groups within the FDA
  • Works with DPQR management to establish collaborations with external stakeholders on advancing the utilization of PAT in pharmaceutical development and manufacturing
  • Develops training materials and courses on PAT applied to pharmaceutical development and manufacturing
  • Develops white papers on emerging topics in PAT for pharmaceutical development and manufacturing
  • Routinely updates management on the status and progress of the PAT-related research projects

Minimum Requirements:

  • Requires a bachelor's degree or higher in a science or engineering discipline (e.g. chemical/mechanical engineering)
  • Minimum four (4) years of experience in applying PAT to address scientific questions.
  • Industrial or government experience applying PAT for processes and/or physical systems.
  • Knowledge and hands-on experience with PAT instruments that can be applied to pharmaceutical manufacturing including unit operations that involve particles, flowing powders, solutions, and suspensions (e.g., near infrared, Fourier transform infrared, and Raman spectroscopy, etc.).
  • Knowledge of chemometrics, multivariate modeling approaches, and data processing methods that can be applied to large data sets (e.g., principal component analysis, partial least squares analysis, linear discriminant analysis, etc.).
  • Knowledge and hands-on experience with a range of software platforms used for multivariate analysis (e.g., Unscrambler, SIMCA, MATLAB, Eigenvector, Python, etc.) and willingness to learn platforms as needed.
  • Knowledge of PAT model development, verification, and validation practices.
  • Attention to Detail - being thorough when planning, developing, and carrying out vital tasks in supporting research projects including PAT method documentation.
  • Customer Service - assisting others in the resolution of issues when integrating PAT, developing models, or interpreting results.
  • Collaboration - willing to participate in interdisciplinary projects working with members and managers on product quality research projects and initiatives.
  • Written Communication - expressing highly technical information (e.g., ideas or facts) to individuals or groups effectively, taking into account the audience and nature of the information, including scientific publications.
  • Oral Communication - expressing highly technical information (e.g., ideas or facts) to individuals or groups effectively, taking into account the audience and nature of the information.
  • Problem Solving - conducting extensive investigation and analysis to determine the nature and scope of problems and devise solutions.
  • Working knowledge of pharmaceutical development and manufacturing is a plus.

Apply online at our website:

Disclaimer: This is not to be an exclusive list of all responsibilities', duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, sex, national origin, religion, age, physical or mental disability, family responsibility, marital status, sexual orientation, political affiliation, veteran's status or any other legal protected status. Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. EOE/AA/M/F/D/V. Please view Equal Employment Opportunity Posters provided by OFCCP here. Successful candidate must pass, comply and adhere to KIC's Drug and Alcohol policy/testing requirements and pass a thorough background check including fingerprinting.

Kikiktagruk Inupiat Corporation


Silver Spring, MD
20901 USA



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