Senior Scientist, Engineering

Description

The Senior Scientist, Engineering, will possess an in-depth knowledge of process engineering for the development and production of drug substances. The candidate will provide engineering support to the MS&T group including equipment selection, design, installation, and operation, heat and mass transfer calculations, and scale-up modelling. The candidate will support execution of Phlow's internal API development projects as well as the CDMO business to ensure business objectives are met. 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.

• Provide engineering support to Phlow's MS&T labs to ensure the deliverables to customers' projects are met on time and on budget.
• Independently design, install, and operate batch and continuous processing equipment.
• Perform relevant calculations, modelling, and simulations for scale-up of batch and continuous processes
• 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

• Ph.D. with a minimum 1 year of experience, M.S with a minimum 3 years of experience, or B.S. degree with a minimum 5 years of experience in Chemical Engineering
• Process engineering and API manufacturing experience on multi-kilogram scale.
• Experience installing, operating, and maintaining processing equipment for batch and continuous pharmaceutical processes
• Experience with heat and mass transfer calculations in batch and continuous processes
• Experience with process modelling and computational software (ex., Dynochem, ReactionLab, gPROMS, etc)
• Strong interpersonal and communication skills??

Preferred Qualifications

• Knowledge of ICH and cGMP requirements is a plus.
• 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.