Process Development Manager

Work unit manager who develops, leads innovates, evaluates, novel/new biotherapeutics via approved standard operating procedures (SOPs) and product validation for FDA-regulated, cGMP compliant manufacturing operations under the intellectual and scientific guidance of process development director, senior scientists, and managers. Responsible for the management of the Process Development team. Develops goals with respect to CRM projects in the translational pipeline to drive advances in efficiency, value and utility of data from Proof-of-Concept to early Clinical Trials. Works closely with the team in Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs and the associated Principal Investigators. Responsible for highly and moderately complex and physical, chemical, or biological operations using equipment and procedures. Supervises process development scientists and technicians.

This position is a hands-on role as well as supervisory,  

PhD in bioengineering, biotechnology, biological science, pharmaceutics, chemistry, tissue engineering/biomaterials, immunology, cell/molecular biology or other related science from an accredited institution. Minimum of 5 years experience in biotherapeutics for cell and gene therapies. At least 1 year performing related tasks in an industry environment is preferred. 5 years or more of experience as a manager or director within a research facility, cell processing/cell therapy, tissue bank, biotech or pharmaceutical company required.
 

Leadership experience should include new product development, implementation management, technology transfer, statistical process design, analysis of experiments and/or process/product characterization. 

In addition, must include demonstrated ability to work effectively and collaboratively in a multi-disciplinary environment with physician, scientist, educator, administrative, supervisory, and allied health staff. Must have demonstrated leadership competencies management (e.g. staff, change, complex issues) and operations. Excellent communication skills required.

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.