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

Parexel; Olympia (WA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Full benefits

401K

Paid holidays

Paid time off

Job summary

Parexel is seeking a Principal Scientist I to join a client-site project in Rahway, NJ. This full-time role, as Parexel FSP on assignment, centers on developing and optimizing chemical processes from lab to kilo-scale, contributing to API development in a fast-paced, regulated environment.

The position requires strong experimental skills, data analysis, and collaboration with cross-functional teams, with a focus on safety, quality, and environmental considerations.

Qualifications

• PhD in Chemistry or related field with pharma/biopharma experience preferred.
• Experience with chemical process development and scale-up in pharma/biopharma.
• Strong GLP compliance and laboratory safety practices.

Responsibilities

• Lead chemical process development and scale-up efforts for APIs.
• Plan, execute, and document lab experiments across unit operations.
• Ensure data integrity and GLP compliance in reports and analyses.
• Collaborate with cross-functional teams on process improvements.

Skills

Process development

Scale-up operations

GLP compliance

Laboratory safety

Data analysis

Documentation

Education

PhD in Chemistry

MS in Chemistry + 3+ yrs pharma

Tools

MS Office

HPLC

GC

DoE software

Job description

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.

Description

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.

About Parexel

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us!

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.