Job title: Lead – Process Development Engineer – CRB

Company: Mayo Clinic

Job description: Why Mayo ClinicMayo 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 – 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.

ResponsibilitiesThis 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.Qualifications

• 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.Exemption StatusExemptCompensation Detail$94K – $142K / yearBenefits EligibleYesScheduleFull TimeHours/Pay Period80Schedule DetailsMonday through FridayWeekend ScheduleAs needed per projectInternational AssignmentNoSite DescriptionJust as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives.Affirmative Action and Equal Opportunity EmployerAs an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.RecruiterKaela Peterson

Expected salary: $94000 – 142000 per year

Location: Rochester, MN

Job date: Sat, 18 Jan 2025 08:46:55 GMT

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