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

Parexel•United States-New Jersey-Remote, NJ

2d•Onsite

About The Position

Parexel is hiring a Principal Scientist I to work as a full-time Parexel FSP employee, 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. Project teams combine chemical steps and unit operations commonly used in specialty chemical and pharmaceutical industries. This is primarily a laboratory-based role involving process development at scales from grams to multiple kilograms. The work supports scale-up understanding, process robustness, quality, safety, environmental footprint, and yield; troubleshooting and optimization; and delivery of process intermediates and/or APIs. The scientist works with a range of chemicals, manual and automated laboratory reactors and equipment, and process and analytical instruments. Deskwork includes planning, analyzing, and documenting experiments and preparing clear, concise reports. The role involves fast-paced, hands-on research and technical contributions. The position requires a PhD in Chemistry or a closely related field, or a master’s degree in Chemistry or a closely related field plus at least three years of professional experience in the pharmaceutical or biopharmaceutical industry. Sponsorship is not offered. Parexel describes its FSP CMC Operations group as providing pharmaceutical and biopharmaceutical companies with qualified technical professionals to support development and delivery of new therapies.

Requirements

PhD in Chemistry or a closely related field, or a master’s degree in Chemistry or a closely related field with at least three 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 line with safety and 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 with local and web-based software tools, such as MS Office and data analysis tools.
Strong organizational, interpersonal, written, and oral communication skills for collaboration on cross-functional project teams.
Ability to follow established procedures, policies, and guidelines to meet safety, environmental, and quality requirements.
Initiative and independence in developing, applying, and improving laboratory systems, methods, and best practices.

Nice To Haves

Hands-on experience with laboratory reactors and process equipment, including automated Mettler Toledo EasyMax/Optimax systems.
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 particle physical attribute control at bench and kilo-lab scales.
Awareness of current GLP and/or 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, Mathematica, or similar.
Flexibility to adapt to changing work assignments, priorities, and project timelines.

Responsibilities

Develop and optimize chemical process steps using chemical engineering unit operations for API development.
Work on project teams developing chemical processes that bring APIs through early- to late-stage R&D.
Perform laboratory process development at gram to multi-kilogram scales to understand scale-up issues and improve robustness, quality, safety, environmental footprint, and yield.
Troubleshoot and optimize processes and deliver process intermediates and/or APIs.
Safely handle chemicals and use manual and automated laboratory reactors, equipment, and process and analytical instruments.
Plan, analyze, and document laboratory experiments and write clear, concise reports.
Follow established procedures, policies, and guidelines to meet safety, environmental, quality, and GLP expectations.
Develop, apply, and improve laboratory systems, methods, and best practices.
Collaborate with cross-functional project teams.