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

About the role

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are looking to fill a Principal Scientist I position working as a full-time employee of Parexel FSP on assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship.

About the role

The Chemical Engineering Research and Development department of one of our clients in Rahway, NJ is seeking a motivated and technically focused chemist who is looking for an opportunity to develop and optimize chemical process steps combining a series of typical chemical engineering unit operations used in the specialty chemical and pharmaceutical industries (e.g. reactions, extractions, distillations, crystallizations, filtrations, drying).

The individual would do this as part of project teams working together on chemical processes combining multiple chemical steps in order to bring new active pharmaceutical ingredients (APIs) through the R&D pipeline from early through late-stage development.

This position is largely a laboratory-based role to support chemical process development performed at scales spanning the range from grams to multi-kilogram scale in order to understand scale-up issues, improve process robustness, quality, safety, environmental footprint and yield, troubleshoot issues, optimize, and deliver process intermediates and/or APIs.

This role requires the ability to work in the lab with a variety of chemicals, use an array of manual and automated laboratory reactors/equipment and process/analytical instruments. Deskwork will involve planning, analysis, and documentation of laboratory experiments, and writing clear and concise reports. The role offers fast-paced, hands-on research that requires a high degree of technical skills and contributions.

Qualifications

• Principal Scientist I - PhD in Chemistry or closely related field (Biochemistry, Analytical Chemistry, Research Sciences, Material Sciences, etc.); or MS degree in Chemistry or a closely related field (Biochemistry, Analytical Chemistry, Research Sciences, Material Sciences, etc.) with 3+ years of professional experience in pharma/biopharma industry.

Required Skills and Experience

• Demonstrated experience with chemical process development, scale-up, and unit operations including reactions, extractions, distillations, crystallizations, filtrations, and drying.
• Strong laboratory skills with the ability to safely handle a wide variety of chemicals, execute experiments, and generate, analyze, and document 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.
• Proficiency with computers and experience using local and web-based software tools (e.g., MS Office, data analysis tools).
• Strong organizational, interpersonal, written, and oral communication skills to effectively collaborate within cross-functional project teams.
• Demonstrated 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.

Desired Skills and Experience

• Hands-on experience with laboratory reactor and process equipment, including automated systems such as Mettler Toledo EasyMax/Optimax.
• Experience using in-situ or off-line analytical and characterization techniques such as HPLC, GC, FTIR, Raman, FBRM (Focus Beam Reflectance Measurement), PVM, KF, or DSC.
• Familiarity with statistically designed experimentation, including Design of Experiments (DoE) methodologies.
• Experience with API crystallization, isolation, drying, and particle physical attribute control 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 (e.g., PHA, LOPA), or environmentally sound process design.
• Exposure to mathematical modeling, data analysis, or simulation tools (e.g., Aspen, MATLAB, Mathematica or similar).
• Experience with PHA's, Layers of Protection Analysis or similar risk evaluation methodologies.
• Flexibility to adapt to changing work assignments, priorities, and project timelines.