Lead Advanced Biomanufacture Engineer (Center for Regenerative Biotherapeutics)

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.

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.

Responsibilities

Work unit engineer who develops, innovates, evaluates, and implements, methodologies, technologies, or products for the laboratory under the intellectual and scientific guidance of CRM management. Responsible for preparing for and execution of manufacturing batch records, work instructions and / or SOPs. Maintain up to date training records and documentation of all activities to meet cGMP requirements. Maintain cGMP compliance in assigned work. Participate in other required activities (perform safety inspections; participate in improvement projects, etc.).

Qualifications

Bachelor’s degree and 10 years of relevant industry / academia experience or Masters degree in bioengineering, engineering, biological science, chemistry, immunology, cell / molecular biology, or other related science from an accredited institution with 5-7 years of relevant industry / academia experience.Masters degree from an accredited institution in chemical, physical, biological, immunological, cell / molecular or bioengineering or Doctoral degree (PhD) in chemical, physical, biological, immunological, cell / molecular or bioengineering preferred. 5-7 years of manufacturing experience. cGMP clean room experience required. Experience in process development and process characterization of scale-up / scale-down cell manufacturing processes, including optimizing process parameters, cell concentrations and therapeutic product fill and finish.

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 data collection, organization, analysis and delivery of information.

Preferred Experience & Qualifications : The ideal candidate will have strong leadership skills, a deep understanding of cGMP standards, and experience with aseptic technique in cleanroom manufacturing.