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.
- 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.
The salary range for this position is $120,000 to $150,000, with the final offer determined based on factors such as the candidate's experience, qualifications, skills, and education. In addition to a competitive base salary, this position is eligible to participate in Phlow's bonus and stock option programs. Phlow also offers a comprehensive benefits package that includes medical, life, and disability insurance; retirement savings plans; paid time off and company holidays; and education-related benefits. Many of these programs are fully funded or significantly subsidized by the company, reflecting our commitment to supporting the health, well-being, and professional development of our employees.
Requirements
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 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.
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.
