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Joining the ThermoGenesis Team!

Explore the exciting career paths at ThermoGenesis. Making a difference in the million of lives begins with being a part of a team. We offer competitive benefits and opportunities to achieve your full potential with growth-driven training and development.

Open Positions

POSITION: Principal Scientist

DEPARTMENT: Scientific Affairs

POSTING DATE: January 30, 2020

Responsibilities and Duties

This position will be responsible for leading independent therapeutic development projects to meet the company’s needs in the areas of CAR-T immunotherapy, regenerative medicine and other cell-based therapeutic fields.

  • Lead multi-disciplinary laboratory team
  • Strong design of experiment capabilities
  • Designing R&D studies and performing in-vitro and in-vivo bench experiments to develop clinical protocols
  • Validation of biological elements of developed clinical protocols
  • Improve existing protocols and procedures and develop new applications and products
  • Review internal protocols and reports to support internal and external R&D projects
  • Knowledge and past experiences to procedures, instructions and policies in compliance with GLP and cGTPs is preferred
  • Adhere to procedures, instructions and policies in compliance with GLP and cGTPs.
  • Prepare scientific manuscripts, white papers and posters to publish in peer-reviewed journals and support marketing activities
  • Experience in human immunology, hematology and cancer biology, strongly preferred

Qualifications and Skills

  • Ph.D. in life sciences with at least 5-8 years of professional experience. Targeted areas of research should include bioactivity analysis of stem, progenitor or therapeutic cell(s), identification of surrogate markers for cell target bioactivity, understanding of on-target and off target implications of therapeutics under research cell analysis techniques: including culture techniques such as cell isolation, characterization, culture and maintenance, bioactivity assays, genetic stability testing, potency and viability assays
  • Cell analysis techniques:  including advanced flow-cytometry, hemocytometry, and immunofluorescence
  • Experience with assay development and immunology is also highly desired
  • Experience translating bench top experiments into pre-clinical animal models and pre-clinical animal models into early phase human clinical studies
  • Must be able to review scientific databases and accumulate information on relevant clinical trial programs
  • Knowledge of intellectual property development is highly desirable
  • Experience in preparation of grant applications and technical reports is desirable
  • Must be able to professionally represent the company at national and international scientific conferences, meetings and customer sites

 If you are interested and meet these qualifications, please write a cover letter to officially apply for the new position.  The cover letter should clearly explain your interest in the job and delineate how you are qualified for the job.  Email letter along with resume to Human Resources at hr@thermogenesis.com.

POSITION: Sr. Quality Engineer

DEPARTMENT: Quality

POSTING DATE: May 2020

Position Summary

  • The Company is currently seeking to recruit a local Sr. Quality Engineer so support the design and manufacturing of Electro-Mechanical Devices to achieve quality and business objectives through sustaining and continuous improvement activities.
  • Ensures compliance to 21CFR820, ISO 13485, the Medical Device Directive, other applicable regulatory and industry standards.
  • Effectively assess risk of design changes and process controls to assure high quality.
  • Analyze quality system data (field complaints, nonconforming product, etc.) to identify adverse trends and opportunities for continuous improvement.

Responsibilities and Duties

  • Directly involve and support manufacturing and inspection of production from raw material receiving to shipping finished products.
  • Regularly monitor, investigate and review nonconformance activities and generate CAPAs/SCARs based on trends/issues identified from operations, MRB and drive them to closure.
  • Perform thorough root cause analysis investigations for nonconforming product, field complaints, and supplier issues; and implement effective corrections and/or preventive actions.
  • Review change orders to ensure justification, impact level, and evidence of required activities are properly documented.
  • Facilitate Risk Management and support Design Control activities throughout the product lifecycle.
  • Perform internal audit to ensure effectiveness of quality system processes
  • Ensure suppliers deliver quality parts, materials, and services by effectively qualifying and monitoring supplier performance.
  • Uphold company compliance programs in support of government standards including FDA Quality System Regulation 21 CFR 820, ISO 13485, EN, MDD, Canadian, UL and CSA regulations.
  • Enable high product quality by ensuring “built in reliability and Quality by design” during product design and development technical reviews and with manufacturing partners.

Qualifications and Skills

  • Bachelor’s Degree in Mechanical Engineering or Electrical engineering is required.
  • Candidate must have a minimum of 5 to 8 years of electro-mechanical medical device experience.
  • Technical writing of manufacturing procedures, work instructions, test protocols and reports.
  • Experience in Root Cause Analysis and Corrective Action/Preventative Action (CAPA).
  • Product Risk Management throughout the product lifecycle.
  • Standard statistical principles, theories, concepts, and techniques
  • Design Controls in accordance with 21 CFR 820
  • Project management of process/product improvements
  • Quality Management Systems (ISO 13485, 21 CFR 820)
  • Failure investigations in a manufacturing environment
  • Blueprint reading and interpretation including Geometric Dimensioning and Tolerance (GD&T) is preferred
  • Represent Quality/Validation needs on multifunctional design teams and Project/Program Core Teams
  • Experience in software development and validation
  • High performing leadership skills, prioritization, communication (verbal and writing)
  • Self-starter, motivated, able to prioritize tasks and meet deadlines
  • Excels in use of Microsoft Office suite
  • Process Excellence (Six Sigma) and/or ASQ certifications is preferred

 If you are interested and meet these qualifications, please write a cover letter to officially apply for the new position.  The cover letter should clearly explain your interest in the job and delineate how you are qualified for the job.  Email letter along with resume to Human Resources at hr@thermogenesis.com.

 

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