Senior Staff Scientist - Process Development - MSAT

This position can be located at one of our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida or Rochester, MN.

Work unit scientist who develops, leads, innovates, and evaluates biomanufacturing process improvements; facilitates transition of new products into manufacturing and provides technical expertise and troubleshooting during manufacturing operations supporting approved standard operating procedures (SOPs) and product validation for FDA-regulated, cGMP compliant manufacturing operations. 

Responsibilities will include leading design and execution of studies in support of clinical translation of novel biotherapeutics, targeting manufacturing science and technology (MSAT) in CRB. Optimization and investigation of process issues to target process scale for improvement of existing methods or implementation of novel technology of proven validity. Supervises junior scientific staff and provides direction to junior scientists and process development technologists. Assists in analysis of data. Reviews and signs off on SOPs, technical studies and reports, batch documentation and laboratory notebooks in a compliant manner. Participates in drafting regulatory documentation for FDA submission. Participates in forecasting project budgetary needs. 

Guides the development of release test methods, maturation of research analytical methodology into development and cGMP, and analytical method technology transfer from and to our facilities and/or contract vendors. Plans, guides and assists in executing laboratory studies to optimize and troubleshoot manufacturing processes, ensuring alignment with regulatory requirements.  Oversight on readying project transition into clinical manufacturing. Trains manufacturing personnel in final product manufacturing processes.

• PhD in biological science, chemistry, immunology, cell/molecular biology, bioengineering or other related science from an accredited institution with 8 plus years of relevant industry/academia experience in production of biotherapeutics. 
• Prefer MSAT experience
• 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 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 various data collection and organizational systems, analysis and delivery of information. 
• Experience managing scientific staff.

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 flexible coverage.
• Vision: Affordable plan with national network.
• Pre-Tax Savings: HSA and FSAs for eligible expenses.
• Retirement: Competitive retirement package to secure your future.