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: Sr. Director of Scientific Affairs

DEPARTMENT: Scientific Affairs

POSTING DATE: October 29, 2019

Responsibilities and Duties

This position will be responsible for designing and executing laboratory studies to support the development and performance validation of ThermoGenesis products that automate the manufacture and cryopreservation of target cell populations including genetically engineered autologous cells for clinical use.

  • Managing all laboratory staff
  • 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
  • Train and transfer the clinical protocols to clinical teams
  • Improve existing protocols and procedures for X-Series® devices and CAR-TXpress™ Platform products
  • Review literature and prepare meta-analysis to support research and clinical trial programs
  • Review internal protocols and reports to support clinical R&D projects
  • 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

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 experience should include 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 is also highly desired
  • Experience translating bench top experiments 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: Manufacturing Engineer

DEPARTMENT: Engineering

POSTING DATE: October 24, 2019

Responsibilities and Duties

Manufacturing Engineer (Medical Devices) – Provide support for cleanroom manufacturing operations, new technology introduction, manufacturing development, process validation and day to day manufacturing activities. This position requires knowledge of the production and process development of medical devices. The position involves the sustaining engineering activities for existing products, installation of manufacturing equipment and transfer of new technologies to production.  Experience needed in relevant validation protocols (IQ, OQ, PQ) involving all aspects of process and product validation, i.e. manufacturing process instructions, test protocols, manufacturing software, design of experiments, engineering studies, root cause analysis and the creation of pFMEA’s.  This position will frequently require participation in cross-functional teams in which the engineering activities are coordinated through project plans.  The manufacturing engineer is required to be comfortable with providing technical leadership for operations personnel and presentation of technical data to management.

Major Activities:
Apply engineering principles to the manufacturing of medical devices in a cleanroom environment. This position will place an emphasis on knowledge of plastics methods of assembly for small to medium scale volumes. Essential activities will include:

  • Improve product manufacturability
  • Perform engineering analyses as it pertains to troubleshooting, verifications, writing and conducting test protocols
  • Establish manufacturing solutions
  • Initiate and review manufacturing process instructions (MPIs)
  • Participate in Material Review Board (MRB) to address nonconforming assembly/components
  • Conduct feasibility studies
  • While working as a member of a multi-functional project team, changes to products to be developed in adherence to specified Design Control and Product Development
  • Processes while achieving performance that satisfies product specifications within planned time frames
  • Participate in transfer-to-manufacturing activities and establishment of process validation for product assembly
  • Work with external suppliers (Contract Manufacturers, distributors, etc.) to sustain existing products
  • Effectively communicates verbally and in writing with Engineering Management as well as all functional areas within the organization

Qualifications and Skills

  • B.S. in Manufacturing Engineering
  • 5+ years related experience in medical device manufacturing
  • SolidWorks parts, assemblies and drawings. Inventor knowledge a plus.
  • Strong analytical and problem-solving skills.
  • Solid understanding of plastics fabrication and methods of assembly.
  • Ability to write technical documents in support of essential job functions.
  • Ability to define the objectives, requirements, and assumptions necessary to structure and schedule a small project.
  • Effective communication, teamwork, and time management.
  • Familiar with medical device risk management a plus.
  • Experience with medical devices and systems that incorporate mechanics, electronics and software a plus

 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: Director of Biology

DEPARTMENT: Research and Development

POSTING DATE: March 14, 2019

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 (DOE) capabilities
  • Designing R&D studies and performing in-vitro and in-vivo bench experiments to develop and validate protocol
  • Develop and validate new assays for product developments
  • Develop and validate new cellular processing for the cell-based therapeutics, develop new applications
  • 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
  • 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
  • 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: Research Associate

DEPARTMENT: Quality Engineer

POSTING DATE: October 29, 2019

Responsibilities and Duties

  • Support the 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 asses 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.
  • 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
  • Blue print 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.

POSITION: Quality Assurance Supervisor

DEPARTMENT: Quality Assurance

POSTING DATE: October 29, 2019

Responsibilities and Duties

Executes medical device quality assurance initiatives in accordance with the US Food and Drug Administration’s Medical Device Quality System Regulation (21 CRF 820), Medical devices, Quality management systems (EN ISO 13485) and internal policies and procedures. This position leads the quality operations support for manufacturing and controls acceptance of materials from receiving through final product release.

Identification and traceability

  • Execute the process of product and equipment identification and traceability during stages of receiving inspection, quarantine and final inspection

Production and Process Controls (Deviations, Equipment, Labels)Execute the process for control of process deviations

  • Execute the process for control of inspection, measurement and test equipment and work with technical resources to verify the equipment is suitable for its intended purpose
  • Support and troubleshoot production label operations

Acceptance Activities

  • Execute the process for conducting first article, receiving, and final acceptance inspections using special inspection tools and processes

Nonconforming Product and Process

  • Execute the process for controlling nonconforming materials, assemblies or final product and processes
  • Ensure proper identification, documentation and segregation is conducted. Coordinate completion of evaluation and disposition with technical resources for CAPA and SCAR

Records

  • Assure records resulting from quality operational activities are maintained, controlled and transferred to appropriate record archival locations as designated by the company Quality Policy

Complaints

Execute Complaint review tasks as required to maintain regulatory compliance. Including but is not limited to:

  • Regulatory reporting assessment (MD/VR)
  • Assist investigation
  • Complaint database maintenance
  • Management reporting and metrics
  • Support process contributors
  • Complaint file closure audit

Audits

Support internal and external audits. Including but is not limited to:

  • Audit management
  • Documentation/record retrieval
  • Database maintenance
  • Correction and Corrective Action response to audit non-conformances

Additional Functions

  • Maintain functional procedures and revise as necessary
  • Process tasks in accordance with company timelines
  • Assess and evaluate workload against agreed processing timelines
  • Track and trend process metrics
  • Escalate issues to management as necessary
  • Lead functional continuous improvement projects

Qualifications and Skills

  • Bachelor’s Degree degree preferred
  • High School diploma with relevant trade school or college level courses in a related area would be considered
  • Minimum 5 years’ experience in a medical device Quality Assurance capacity
  • In depth knowledge of quality systems integration
  • Involvement in regulatory body inspections
  • Knowledge of ISO13485, 21 CFR 820, measurement tools
  • Highly motivated and dedicated to Quality Principals
  • Organized, though, and detailed oriented
  • Experience in Quality Management System software, Enterprise Resource Planning systems, Microsoft Office suite
  • Decision making, analytical and problem-solving skills

 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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