ApplyDescription
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 the ongoing continuous improvements in manufacturing processes resulting in improving product quality, robustness, and cost.
- Collaborate with Analytical Chemistry, EH&S, 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 functional expertise in modern synthetic organic chemistry, compound purification, spectral analysis/interpretation.
- Experience with searching the chemical literature to evaluate potential solutions to synthetic problems.
- Experience with common analytical techniques such as: HPLC, GC, NMR, UV, LC-MS
- Strong interpersonal and communication skills??
Preferred Qualifications
- Ph.D. with a minimum 5 years of experience, M.S with a minimum 10 years of experience, or B.S. degree with a minimum 15 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).
- 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.
Physical Requirements
- 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.
- This position may require up to 5% travel with occasional increase in travel demands based on business needs.
