Lead - Process Development Engineer - CRB

This position within the Center of Regenerative Biotherapeutic’s Process Development team will be responsible for leading the development upstream and downstream manufacturing processes, analytical methods, and the characterization of cellular and non-cellular therapies at Mayo Clinic and/or in collaboration with industry partners.  This role will focus on developing scalable processes that drive projects forward to support our programs.

Demonstrated experience with:

• Deep understanding principles, methodologies and concepts related to cell culture and bioreactor scale up operations.
• Experience with mid-scale bioprocessing experience and exposure to running 0.5-20L bioreactors.
• Aseptic technique and experience in cell culture work with human multi-pluripotent stem cells and/or immune cells
• Experience in utilizing analytical methods to characterize processes including cell-based assays and flow cytometry
• Maintain a comprehensive Electronic Lab Notebook documenting experiments
• Knowledge of GMP and GLP environments is preferred.
• Evidence of "hands-on" experience and expertise in design of experiments (DOE) and statistical analysis.
• Excellent communication skills to exchange complex technical/scientific information with others in complex situations.
• Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities. 

Work unit lead process developer who innovates, evaluates and develops procedures for generating novel biotherapeutics via standard operating procedures (SOPs) and product validation for FDA-regulated, GMP compliant manufacturing operations under the intellectual and scientific guidance of process development director/s and scientists. 

Responsibilities will include the design and execution of technical studies to develop robust manufacturing processes for cell therapy products and implementation to support programs in clinical development.  Evaluates novel and emerging technologies to advance project strategy as well as developing robust, scalable processes. Analysis, organization, and presentation of data in a clear and concise manner. Creation of batch documentation, maintenance of electronic laboratory notebooks and preparation of protocols and reports in a compliant manner.

Leads the development of release testing methods and the formalization of analytical methodologies into GMP compliant processes. Facilitates analytical method technology transfer to and from our facilities and/or contract vendors. Executes laboratory studies, analyzes experimental data and carefully documents resultant information. Assists in training manufacturing personnel in final product manufacturing processes.

• Bachelor's degree in biological science, chemistry, immunology, cell/molecular biology, bioengineering or other related science from an accredited institution.
• 7+ years of related process development or laboratory experience within the biologics industry. 
• Master's degree from an accredited institution in chemical, physical, biological, immunological, cell/molecular or bioengineering preferred.
• Self-motivated, highly organized, efficient, and able to work independently exercising strong decision-making skills. 
• Excellent written and verbal communication skills are necessary. 
• Capable of leading process development project efforts to facilitate translation of biotherapeutics into clinical production. 
• Practiced at reproducing a reference method using available procedures without supervision. 
• Demonstrated analytical and scientific competency with process development and/or validation of lab techniques or procedures. 
• Experience with data collection, organization, analysis and delivery of information.

Visa sponsorship is not available for this position.  This position is not eligible for F-1 OPT STEM extension.

Why Mayo Clinic
Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You’ll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.
Benefits Highlights

• Medical: Multiple plan options.
• Dental: Delta Dental or reimbursement account for flexi