Principal Scientist

Description

The Principal Chemist 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, and partners.

Responsibilities:

• Provide process chemistry support to Phlow's Continuous Manufacturing R&D lab to ensure the deliverables to customer's projects 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.

Requirements

Preferred Qualifications:

• 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.

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.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.