Senior Principal Scientist, Process Chemistry Job at Phlow, Virginia

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  • Phlow
  • Virginia

Job Description

Description The purpose of this role is to provide process chemistry support to Phlow's Advanced Manufacturing R&D lab. The Senior Principal Scientist will possess an in-depth knowledge of process chemistry skills for the development of synthetic routes for drug substances. The candidate will perform multi-step chemical syntheses and product isolation/purification operations in the laboratory either independently or as part of a project team. The candidate will ensure excellence of our process development and technical transfer to Phlow's partners or customers. The candidate will personify Phlow's shared values and culture, both internally and externally. The candidate will work with the highest standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues. Requirements Essential Job Duties & Responsibilities Provide process chemistry support to Phlow's Advanced Manufacturing R&D lab to ensure project deliverables are met on time and on budget. Independently design, synthesize, purify, and analyze chemical intermediates, target compounds, and impurities. Maintain accurate, legible, and complete records of all experiments and observations. Author progress reports and present scientific results to team members. Exhibit a high level of safety awareness and conduct lab operations in a safe manner. Contribute to the timely and accurate preparation of regulatory submissions. Participate in ongoing continuous improvements in manufacturing processes to enhance product quality, robustness, and cost efficiency. Collaborate with Analytical Chemistry, EHS, Engineering, Project Management, Quality Assurance, and Regulatory Affairs to ensure strong working relationships with all partners and Phlow employees. Experience & Qualifications Minimum of 5 years working in related roles in the pharmaceutical industry. A broad range of expertise in modern synthetic organic chemistry, compound purification, spectral analysis, and interpretation. Experience with searching chemical literature to evaluate solutions to synthetic problems. Experience with analytical techniques such as HPLC, GC, NMR, UV, LC-MS. Strong interpersonal and communication skills. Preferred Qualifications Ph.D. with at least 5 years of experience, M.S. with at least 10 years, or B.S. with at least 15 years in Organic Chemistry, Pharmaceutical Sciences, or a related field. Process chemistry and API manufacturing experience on multi-kilogram scale. Knowledge of ICH and cGMP requirements. Experience working for CROs, CMOs, or CDMOs. Experience with risk assessments such as process robustness, mutagenic impurities, nitrosamines, etc., is a plus. Experience with DOE and multivariate experimentation approaches is a plus. Experience with continuous flow manufacturing process development is a plus. Physical Requirements Constantly required to view computer screens and monitors for reading, writing, presenting, and communicating. Frequently required to talk or hear for communication with others, including presentations. Frequently required to reach with arms and hands, perform repetitive motions, and work at a computer keyboard and mouse. Frequently required to sit; occasionally required to stand or walk. Occasionally lift and/or move up to 10 pounds. May require up to 5% travel, with potential for increased travel based on business needs. #J-18808-Ljbffr Phlow

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