PROCESS ENGINEERING SCIENTIST (PDE-003)

General Job Description/Team Overview: 

As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery, this position will support the research, development, and manufacturing groups in the process design of early-phase process development. The position is ideal for a self-motivated individual, who is excited to work in a startup environment with opportunities to rise to frequent and diverse challenges. This position will act as a liaison between R&D and PD, to initiate experiments deemed important to test for future product pipelines. The level will be determined based upon the candidate’s education, skills, and/or related experience.

Primary Duties and Responsibilities (include but are not limited to):

• Verify and validate cell lines received from RD perform as identified. 

• Optimize process design using new technologies and products to increase efficiencies and decrease the cost of goods and decrease manufacturing costs. 

• Expand the cell lines as needed before performing any PD experiments. 

• Design experiments to find the most optimal growth, and potent vector production. 

• Perform experiments in scale down model, such as in shake flasks and benchtop bioreactors.  

• Prepare for tech transfer into late-phase PD. 

• Identify and document new technologies and processes for process transfer. 

• Demonstrate and validate process design ideas with proper data analysis.  

• Troubleshoot and isolate problems in PD laboratory equipment. 

• Help manage external projects and collaborations.

 • Perform other duties as assigned.   

Required Qualifications:

• Master’s degree or Ph.D. in Bio-Engineering, or other relevant degrees, or equivalent technical experience. 

• 2-3+ years of process engineering experience involving: API, chemical processing, cell culture, upstream and downstream purification, single-use, and multiple-use technologies. 

• Proficient at process design using first engineering principles to evaluate power distribution, kLa, energy dissipation rate to model and predict scale up and scale down.   

• Proficient in reading and creating electrical schematics and using manufacturers’ product data sheets to select components to purchase. 

• Strong understanding of chemical engineering principles, engineering lifecycle related to process design. 

• Ability to define problems collects data, establish facts, and draw valid conclusions. 

• Strongly motivated, well organized, and a team player with a willingness to learn new techniques. 

• Strong quantitative and qualitative analytical skills. 

• Ability to manage multiple tasks simultaneously. 

• Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable. 

• Excellent organization skills with attention to detail and accurate record keeping. 

• General knowledge of Federal and State regulatory requirements in a GxP environment. 

• High degree of discretion dealing with confidential information. 

• Ability and willingness to work flexible hours when needed. 

• Demonstrated ability to work independently and in a team environment. 

• Excellent written, verbal, and interpersonal communication skills. 

• Eligible to work in the U.S. 

Job Type: Full-time