Loading...
Careers 2019-09-03T15:48:20+00:00

ThermoGenesis, a wholly owned subsidiary of Cesca Therapeutics, is a pioneer and market leader in the development and commercialization of automated technologies for cell-based therapeutics and bio-processing. We’re dedicated to advancing technologies and improving lives.

Open Positions
___________________________________________________________________

POSITION:                        Director of Biology

DEPARTMENT:                 Scientific Affairs

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:                         Clean Room Operator

DEPARTMENT:                  Manufacturing Operations

POSTING DATE:                July 9, 2019         

Responsibilities and Duties

  • Use various tools and equipment to produce assemblies to written specifications
  • Use various measurement devices to record data for in-process inspections
  • Maintain inventory accuracy by performing daily counts in area of responsibility
  • Implements improved documentation
  • Improves overall compliance
  • Ability to work with a microscope for failure investigation
  • Ability to read/write English and communicate effectively
  • Communicate effectively noticed problems with assemblies and or equipment being used
  • Determine the difference between good/pass and bad/failed parts/assemblies
  • Anticipates and troubleshoots problems

Qualifications and Skills

  • High School diploma or equivalent Prefer ERP experience.
  • 5+ years’ experience in a cleanroom is required
  • Ability to perform basic mathematical calculations
  • Advanced equipment operating skills are necessary
  • Experienced in mechanical troubleshooting techniques
  • Knowledge of glue dispensing, UV curing, solvent bonding and glue robot processes
  • Ability to take direction from engineering and build prototypes as required
  • Experience assembling medical devices in a CGMP environment.

Physical Requirements

  • Ability to lift up to 35 lbs.
  • Prolonged sitting required, up to 8+ hrs/day

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:                          Ph/D Scientist

DEPARTMENT:                  Research and Development

POSTING DATE:                  July 23, 2019  

Responsibilities and Duties

 This position is to carry out and perform independent research and experiments to support the company’s ongoing projects in cell processing and cell therapies.

  • Execute laboratory experiments, tests and studies (studies) in support of the company’s ongoing projects.
  • Strong hands on experiences in tissue culture, flow cytometry, and various cellular function assays.
  • Strong literature search skills.
  • Proven track records of scientific presentation and communication.

Qualifications and Skills

  • Ph.D. in Cell Biology, Immunology, Genetics, or other life science field.
  • 0-5 years of post-graduate experiences.
  • Strong communication skills (oral and written) are required.
  • Highly motivated and independent.

 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:                            Regulatory Affairs Specialist
DEPARTMENT:                   Regulatory Affairs
POSTING DATE:                 August 29, 2019

Responsibilities and Duties

Responsible for providing support in obtaining new domestic and international registrations and licenses and maintaining registration/license renewals. Monitor renewal schedules in collaboration with authorized representatives, sponsors, and distributors. Responsible for obtaining regulatory inputs for product labeling and coordinating the development and maintenance of the labeling. Assists with coordinating and/or participates with regulatory inspections, quality audits, and completing post inspection/audit actions. Monitors and maintains regulatory process metrics, and participates in regulatory and quality based continuous improvement projects. Provides back-up support for document control:

Regulatory Affairs

  • Responsible for providing documentation as requested from distributors, sponsors, or authorized representatives to support product registrations or renewals worldwide.
  • Serves as aa member of the Regulatory Affairs team in preparing Master Access Files and pre-market submissions for USA FDA clearance to market and/or approvals.
  • Participates on project teams to provide regulatory input and support; including gathering of post-market documentation.
  • Serves as the label development subject matter expert. Mentors users on protocols for label change control (standards for graphical content, branding, layout, material and print validation) collaborates with stakeholders on content and design of labels using in the appropriate label software.
  • Provide support as necessary for submitting adverse reporting and vigilance documentation to regulatory authorities.
  • Maintains knowledge of current applicable regulations, standards, guidance documents and best practices.

Quality Systems

  • Updates regulatory process SOPs and maintains records as necessary to support quality system compliance.
  • Gathers and monitors Regulatory System metrics. Provides reports and escalates adverse trends to management.
  • Provides back up support to the Document Control function as necessary.

Overall Compliance and Continuous Improvement

  • Promotes quality system concepts and regulatory requirements.
  • Identifies opportunities for improvement in the RA and QMS programs.
  • Leads or participates in nonconformance, corrective action and preventive action investigations and action plan implementation as well as continuous improvement projects as necessary.
  • Provides support during compliance and quality system audits as required.

Qualifications and Skills

Education

  • Bachelor’s Degree in a related field preferred. Minimum High School diploma with relevant trade school or college level courses in a related field.

Required Experience

  • Minimum of 5 years previous experience in medical device, or related industry.
  • Minimum of 2 years previous experience in Regulatory Affairs; domestic and international preferred
  • 21 CFR 820 System Regulation, Medical Devices; CGMP (US)
  • 93/42/EEC Medical Device Directive (EU) or equivalent
  • ISO 13485 Medical Device Quality Management Systems
  • Medical device labeling standards
  • Document/Record Control systems; electronic preferred

Skills

  • Highly motivated and dedicated to quality principals.
  • Organized, thorough, and detailed oriented.
  • Experience in Quality Management System software, Enterprise Resource Planning systems, Microsoft Office suite.
  • Solution driven, analytical and problem-solving skills.
  • Excellent prioritization and communication (verbal and written)

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 Inspector
DEPARTMENT:                   Quality Assurance
POSTING DATE:                 September 4, 2019

Responsibilities and Duties

Conducts inspection of incoming materials, components, sub-assembly, and finished goods in accordance with approved specifications using standard and specialized tools such as calipers, pin gages, height gauge, micrometer, as well as approved visual and functional inspection methods such as a light pad, meters, centrifuge and pull tester. Has authority to accept or reject materials, components, sub-assembly, and finished goods in accordance with the requirements of the material/product specification.

  • Develops, evaluates, and applies technical quality assurance protocols and methods to inspect and test first articles, incoming materials, sub-assembly, and finished goods.
  • Ensures suppliers deliver quality parts, materials, and services.
  • Ensures that inspection, sampling, and statistical process control procedures are followed.
  • Maintain clear and accurate records including inspection attribute data, material certifications, testing results, and non-conformances.
  • Maintain material identification throughout the inspection process.
  • Assures compliance to the ThermoGenesis Quality System, ISO 13485, GMP and GDP regulations.
  • Monitors and records chart readings for temperature controlled storage areas.

Qualifications and Skills

  • Applied knowledge of Sampling plans, methods and mechanical inspection tools.
  • Strong mechanical and electrical background and aptitude.
  • Organized, thorough, and detail oriented.
  • Empirical knowledge of production/manufacturing methods, and processes.
  • Applied use of ISO 9001 quality standards, preferred understanding of the medical device requirement (21CFR820, ISO 13485).
  • Accomplished in use of desk/laptop computers
  • Accomplished in use of MS Word, Excel, ERP and QMS systems.
  • 3-5 years in quality assurance/control.
  • Knowledge and ability to read CAD drawing systems including tolerances, reference and critical inspection dimensions.
  • Must be able to lift to 20 lbs.
  • Must be able to stand up to 2 hours continuously

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.

___________________________________________________________________

Cesca Therapeutics/ThermoGenesis is an Equal Opportunity Employer

___________________________________________________________________