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Staff Scientist Process Development-CRB

  • Job
    Full-time
    Senior Level
  • Science
    Research & Development
  • Jacksonville

AI generated summary

  • You must have a PhD in a relevant science, 5+ years industry experience, CAR-T or cell therapy expertise, strong communication, analytical skills, and assay development experience preferred.
  • You will lead the development and optimization of cell therapy processes, conduct studies, analyze data, document results, train personnel, and support compliance in cGMP manufacturing.

Requirements

  • Education/Experience Required:
  • PhD (5+ years of relevant industry experience) in chemical/biochemical engineering, biomedical engineering, immunology, cell/molecular biology, or other related science from an accredited institution.
  • Experience in CAR-T cell therapy and similar cell therapy products, bioprocessing, process development, immunology, and/or cancer biology preferred.
  • Experience in development and characterization of cell therapy products, specifically CAR-T 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 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.
  • Experience with assay development highly desired.
  • Preference given to candidates with experience in immune effector cell biomanufacturing.

Responsibilities

  • More specifically, we are looking for a scientist that can lead the development, scale-up and optimization of novel/new biotherapeutics in preparation for cGMP compliant manufacturing operations including cell therapy CAR-T drug products.
  • Develop, optimize, and execute various cell therapy processes including cell culture, cell selection, activation, expansion, and harvest
  • Design and execution of studies to support process optimization for clinical translation of novel biotherapeutics
  • Optimize process steps to target process scale for improvement of existing methods or implementation of novel technology
  • Analysis, organization, and presentation of data in a clear and concise manner
  • Author, review, and coordinate technical documentation such as batch documentation, laboratory notebooks, protocols, and reports
  • Draft and review technical documentation to support clinical production and product validation for FDA-regulated, cGMP compliant manufacturing operations
  • Provides direction and training to junior scientists and manufacturing personnel
  • Exceptional interpersonal and communication skills, effective, efficient, and organized, familiarity with 5S methodology a plus
  • Develop release test methods, maturation of research analytical methodology into development and cGMP, analytical method technology transfer to and from our facilities and/or contract vendors
  • Apply DOE/QBD principals to plan and perform experiments, analyze data, and generate presentations for communication to working group and department wide
  • Familiarity of analytical methods and experience in statistical analysis using JMP preferred

FAQs

What is the primary focus of the Staff Scientist Process Development position at Mayo Clinic?

The primary focus is to lead the development, scale-up, and optimization of novel biotherapeutics, specifically cell therapy CAR-T drug products, in preparation for cGMP compliant manufacturing operations.

What qualifications are required for this position?

A PhD with 5+ years of relevant industry experience in chemical/biochemical engineering, biomedical engineering, immunology, cell/molecular biology, or other related sciences is required.

Is experience in CAR-T cell therapy necessary for this role?

While not strictly required, experience in CAR-T cell therapy and similar cell therapy products, bioprocessing, process development, immunology, and/or cancer biology is preferred.

What skills are essential for applicants?

Applicants should possess strong analytical and scientific competency, excellent written and verbal communication skills, and the ability to work independently with effective decision-making skills.

Are there opportunities for career advancement in this position?

Yes, Mayo Clinic provides continuing education and advancement opportunities, allowing you to build a long, successful career.

Is visa sponsorship available for this job?

No, visa sponsorship is not available for this position.

What is the work schedule for this role?

The schedule is full-time, Monday to Friday, from 8 am to 5 pm, with additional hours as needed.

What kind of benefits does Mayo Clinic offer?

Mayo Clinic offers competitive compensation and comprehensive benefit plans to support employees and their families.

Are there any specific methodologies or analytical techniques that candidates should be familiar with?

Familiarity with 5S methodology, DOE/QBD principles, and experience with statistical analysis using JMP are preferred for the role.

What is the compensation range for this position?

The compensation range is between $97,531.20 and $146,452.80 per year, depending on education, experience, and tenure.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Mayo Clinic has expanded and changed in many ways, but our values remain true to the vision of our founders. Our primary value – The needs of the patient come first – guides our plans and decisions as we create the future of health care. Join us and you'll find a culture of teamwork, professionalism and mutual respect, and most importantly, a life-changing career. Mayo Clinic was founded in Rochester, Minnesota by brothers Dr. William James Mayo and Dr. Charles Horace Mayo. More than 100 years later, their vision continues to evolve around a single guiding value: "The needs of the patient come first." Today we are the largest integrated, not for-profit medical group practice in the world. We are recognized for high-quality patient care more than any other academic medical center in the nation. These endorsements are very gratifying, but also humbling. They remind us of the tradition that has been entrusted to each one of us, and the legacy of excellence that we uphold every day.