Principal Scientist I or II - Synthetic Chemist, Process Development Engineering & Safety - FSP

Parexel•United States-New Jersey-Remote, NJ

1d•Onsite

About The Position

Parexel is hiring a full-time Principal Scientist I or II, working as a Parexel FSP employee and assigned onsite at a client in Rahway, New Jersey. The role is in the client's Chemical Engineering Research and Development department and focuses on developing and optimizing chemical process steps for active pharmaceutical ingredients (APIs), from early- through late-stage development. Work combines typical chemical engineering unit operations, including reactions, extractions, distillations, crystallizations, filtrations, and drying, as part of cross-functional project teams. This is primarily a laboratory-based position supporting process development at scales from grams to multi-kilograms. The scientist will help understand scale-up issues, improve process robustness, quality, safety, environmental footprint, and yield, troubleshoot and optimize processes, and deliver process intermediates and/or APIs. The role involves working with a variety of chemicals and using manual and automated laboratory reactors, equipment, and process and analytical instruments. Desk-based work includes experiment planning, analysis, documentation, and writing clear, concise reports. The position involves fast-paced, hands-on research and requires strong technical skills and contributions. The position does not offer sponsorship.

Requirements

For Principal Scientist I: PhD in Chemistry or a closely related field, or an MS degree in Chemistry or a closely related field with at least 3 years of professional experience in the pharmaceutical or biopharmaceutical industry.
For Principal Scientist II: PhD with 1–3 years of pharmaceutical or biopharmaceutical industry experience, which may include postdoctoral experience, or an MS degree with at least 5 years of professional experience in the pharmaceutical or biopharmaceutical industry.
Demonstrated experience in chemical process development, scale-up, and unit operations including reactions, extractions, distillations, crystallizations, filtrations, and drying.
Strong laboratory skills, including safely handling a wide variety of chemicals, executing experiments, and generating, analyzing, and documenting data in compliance with safety and Good Laboratory Practices (GLP) expectations.
Knowledge of chemistry theory and practice, including process robustness, quality, yield, and environmental considerations.
Ability to work accurately and safely in a fast-paced, regulated laboratory environment with minimal supervision.
Computer proficiency and experience using local and web-based software tools, such as MS Office and data analysis tools.
Strong organizational, interpersonal, written, and oral communication skills for collaboration within cross-functional project teams.
Ability to follow established procedures, policies, and guidelines to meet safety, environmental, and quality requirements.
Initiative and independence to develop, apply, and improve laboratory systems, methods, and best practices.

Nice To Haves

Hands-on experience with laboratory reactor and process equipment, including automated systems such as Mettler Toledo EasyMax/Optimax.
Experience with in-situ or off-line analytical and characterization techniques such as HPLC, GC, FTIR, Raman, FBRM, PVM, KF, or DSC.
Familiarity with statistically designed experimentation, including Design of Experiments (DoE) methodologies.
Experience with API crystallization, isolation, drying, and control of particle physical attributes at bench and kilo-lab scales.
Awareness of current Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP).
Experience with process safety evaluations, calorimetry, hazard analysis such as PHA or LOPA, or environmentally sound process design.
Exposure to mathematical modeling, data analysis, or simulation tools such as Aspen, MATLAB, or Mathematica.
Experience with PHA, Layers of Protection Analysis, or similar risk evaluation methodologies.
Flexibility to adapt to changing work assignments, priorities, and project timelines.

Responsibilities

Develop and optimize chemical process steps and unit operations for APIs from early- through late-stage development.
Work with project teams on chemical processes that combine multiple chemical steps.
Conduct laboratory process development at scales from grams to multi-kilograms.
Assess scale-up issues and improve process robustness, quality, safety, environmental footprint, and yield.
Troubleshoot and optimize processes and deliver process intermediates and/or APIs.
Safely handle chemicals and operate manual and automated laboratory reactors, equipment, and process and analytical instruments.
Plan, analyze, document, and report laboratory experiments.