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Sr Director Advanced Biomanufacturing

Job ID 167210BR Date posted 11/29/2021
  • Rochester, Minnesota
  • Full Time
  • Center for Regenerative Medicine
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Position description
Responsible for cGMP and cGMP-compliant manufacturing within all areas of the Center for Regenerative Medicine (CRM) and ensuring strategic alignment to the declared priorities of CRM. Responsible for the management of the Advanced Biomanufacturing 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. Identifies and drives value added technical advances in closing systems, regulatory requirements, aseptic processing, automation, other technologies, techniques, concepts, equipment and generation of data to qualify process to transfer to manufacturing. Oversees and provides leadership for the build out of new biomanufacturing infrastructure ensuring compliance with all safety, quality, cGMP and applicable regulatory requirements. Works closely with the teams in process development, 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.

  • Ph.D. in Engineering, Cell Biology, Pharmaceutics, Biomaterials, Biotechnology or similar degree.
  • Five years of experience as a manager or director within a research facility, cell processing/cell therapy, tissue bank, biotech or pharmaceutical company required
  • Master’s degree and 7 years experience in biotherapeutics
  • At least 1 year in industry performing related tasks
  • Bachelor’s degree and 10 years experience in biotherapeutics
  • At least 1 year in industry performing related tasks.
  • Leadership experience should include new product development, implementation management, technology transfer, statistical process design, analysis of experiments and/or process/product characterization.

Additional qualifications
  • Experience in biomaterials and scaffolds in Tissue Engineering preferred.
  • Five years or more experience managing a multi-project scientific manufacturing unit, with staff of differing professional levels and experience.
  • Work under deadline pressure.
  • Knowledge of federal regulations CRF210, 211 as pertains to CGMP, ISO9000 and other regulatory guidelines pertinent to manufacturing of biologics under CGMP.
  • 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.

Exemption status

Compensation Detail
Education, experience and tenure may be considered along with internal equity when job offers are extended. The minimum salary every 2 weeks is approx $6111.20, based on a full-time position.

Benefits eligible

Full Time

Hours / Pay period

Schedule details
Monday - Friday, Days

Weekend schedule
As needed based on work unit needs

International Assignment

Site description
Mayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly city that provides a highly livable environment for more than 34,000 Mayo staff and students. The city is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.

Kaela Peterson

As 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.
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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status, or disability status. Learn more about "EEO is the Law." Mayo Clinic participates in E-Verify and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization.

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Job offers

Job offers are contingent upon successful completion of a post offer placement assessment including a urine drug screen, immunization review and tuberculin (TB) skin testing, if applicable.


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