Senior Process Chemist
4 weeks ago
The Principal Scientist will be responsible for leading the development of synthetic routes for drug substances, ensuring excellence in process development and technical transfer to Phlow's partners or customers. The ideal candidate will possess an in-depth knowledge of process chemistry skills and be able to perform multi-step chemical syntheses and product isolation/purification operations in the laboratory.
Key Responsibilities:- Provide process chemistry support to Phlow's Continuous Manufacturing R&D lab to ensure timely and accurate deliverables to customer projects.
- Design, synthesize, purify, and analyze chemical intermediates, target compounds, and impurities.
- Maintain accurate 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 improve product quality, robustness, and cost.
- Ph.D. with a minimum 3 years of experience, M.S with a minimum 7 years of experience, or B.S. degree with a minimum 10 years of experience in Organic Chemistry, Pharmaceutical Sciences, or a related scientific field.
- Process chemistry and API manufacturing experience on multi-kilogram scale.
- Knowledge of ICH and cGMP requirements.
- Experience working for a contract organization (CROs/CMOs/CDMOs) is a plus.
- Experience with technical and operational risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines, etc.) is a plus.
- Experience with design of experiments (DOE) and related multivariate experimentation approaches is a plus.
- Experience with the development and implementation of continuous flow manufacturing processes is a plus.
- Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
- Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
- Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
- Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
- Occasionally lift and/or move up to 10 pounds.
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