Principal Scientist, Continuous Manufacturing

Phlow Corp•Richmond, VA

30d•$120,000 - $150,000•Onsite

About The Position

The Principal Scientist, Continuous Manufacturing, will possess an in-depth knowledge of continuous process engineering for the development and production of drug substances. The candidate will provide engineering support to the R&D group including equipment selection, design, installation, and operation, heat and mass transfer calculations, and scale-up modelling. The candidate will support execution 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.

Requirements

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 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

Nice To Haves

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.

Responsibilities

Provide engineering support to Phlow’s R&D labs to ensure the deliverables to customer’s projects are met on time and on budget.
Lead engineering efforts for pharmaceutical process development in continuous flow mode
Independently design, install, and operate 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.