Principal Scientist I or II - Synthetic Chemist

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 position working as a full-time employee of Parexel on long-term 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 process development laboratories within the clients Chemical Commercialization Technology (CCT) department in Rahway, NJ, is seeking motivated and technically focused individuals who are 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, and drying). They 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, as well as technical support of projects at filing/launch and in routine commercial supply. This position is largely hands-on with laboratory chemical process development performed at scales spanning the range from grams to the 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, review of peer work for accuracy, and writing clear and concise development milestone reports and source documents to support staff authoring regulatory filings. Qualifications Principal Scientist 1, MS degree in Chemistry or a closely related field (Analytical Chemistry, Biochemistry, Pharmacologist, Research Sciences, Toxicologist, Material Sciences, etc.) with 3 years of professional experience in pharma/biopharma industry, or PhD in Chemistry or closely related field (Analytical Chemistry, Biochemistry, Pharmacologist, Research Sciences, Toxicologist, Material Sciences, etc.); or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities to perform Project services. Principal Scientist 2, MS degree with 10 years of professional experience (as stated above), PhD (as stated above with 1-3 of experience in in pharma/biopharma industry (can include post doc), or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities to perform Project services. Required Skills and Experience Academic training in chemical process development and scale-up, and conducting experiments with equipment used in typical unit operations (reactions, extractions, distillations, filtrations and drying). Desired scale-up experience is kg scale up to 20 liters. Understanding and work experience as a synthetic chemist The ability to work independently with a minimum of supervision. Ability to work accurately and safely in a fast-paced environment, including being compliant with cGMP processing when trained and required. Strong verbal and written communication skills Candidates must have proficiency with computers, including experience with local and web-based software. Desired Skills and Experience Experience with chemical process development, scale-up, and conducting experiments with equipment used in typical unit operations, beyond basic academic training Experience conducting assays with key analytical instrumentation, such as HPLC, GC, KF, and FTIR. Awareness of current Good Laboratory and/or Manufacturing Practices (GLP’s, GMP’s) Academic training in basic statistics and/or familiarity with statistically-designed experimentation, such as Design of Experiments (DoE) methodology. This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination. About Parexel A North American clinical operations business within Parexel FSP, which 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. Come Join Us!! 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. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.