Process Development Engineer

The Process Development Engineer position works on the process development and scale-up of new products. This position is part of Process Development and interfaces closely with our Quality Assurance, Manufacturing, and Supply Chain teams. The candidate will work closely with other scientists in cell therapy product development. The position reports to the Vice President, Product Development.

Essential Responsibilities

• Role supports a 24/7 cGMP production operation and must adhere to manufacturing shift schedule.
• Develop and test pilot scale processes for the manufacture of novel products.
• Design experiments to aid in the optimization of downstream processing unit operations (extraction, solid/liquid separation, filtration, purification, etc.) for each novel product.
• Determine mass balances for each unit operation of new processes.
• Create process flow diagrams with cost model overlays for both project planning and validation for the manufacture of novel products.
• Communicate/collaborate with Quality Control, Manufacturing, and Supply Chain to understand requirements and limitations during process scale-up.
• Assist in transitioning new processes to the manufacturing floor.
• Provide feedback on optimization of new and established scaled-up process on manufacturing floor.
• Identify needs and justification for capital equipment purchases and rentals.
• Stay up to date on new equipment and techniques for downstream processing unit operations.
• Analyze and interpret data, prepare cogent data summaries, and communicate results to team members.
• Be highly motivated, highly organized and possess excellent verbal and written communication skills.
• Comply with all safety training and good laboratory practices.
• Design and guide complex experiments and projects using a wide application of complex principles, theories, and concepts.
• Comply with all company policies.

Qualifications/Experience

• Strong desire to make a positive impact
• Positive, can-do attitude.
• Cares more and works harder than others
• Bachelor’s degree in chemical engineering, biological engineering, biomedical engineering, or a related field with 2+ years of relevant experience.
• Master’s or PhD degree in chemical engineering, biological engineering, biomedical engineering, or a related field.
• Knowledge or experience with experimental process design/development, process modeling, financial modeling, and bioprocess equipment scale-up.
• Strong analytical and organizational skills.
• Strong verbal and written communication skills.
• Experience with the Microsoft Office 365 suite of products, including Outlook, Sharepoint, Word, Excel, and PowerPoint.
• Experience with statistical analysis or optimization software to develop and execute using a design of experiments approach.