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.
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 email@example.com.
POSITION: Quality Manager
POSTING DATE: November 17, 2020
ThermoGenesis is currently seeking a Quality Manager with the below qualifications. Local candidates are preferred as there is no relocation package for this position
- Serve as the subject matter expert for the company on compliance issues. Provide guidance and support on matters relating to FDA/FBD/ISO regulations
- Design, develop, implement, manage and maintain an effective quality system to ensure compliance with the applicable ISO 13485, EN, MDD, Canadian, and FDA 21 CFR 820/QSR quality system regulations.
- Facilitate a continuous quality improvement program that allows the organization to establish and reflect a high quality corporate image for customers, suppliers, and regulatory agencies.
- Provide recommendations and guidance to leadership and development teams in support of quality objectives.
- Oversea and manage quality assurance and quality control processes and staff.
- Lead internal and external audits.
Essential Job Functions
- Establish, monitor and maintain an effective quality system to enable compliance with the FDA Quality System Regulation, and applicable ISO, EN, MDD, and Canadian, and other applicable regulations.
- Provide product development team and leadership product development guidance in order to meet product quality expectations.
- Write, review, and approve documents related to quality and regulatory (GMP) compliance. Provide guidance to product development teams in protocol development in support of meeting quality requirements.
- Facilitate the establishment of high quality and compliant corporate image.
- Collect, analyze and report quality system management data matrix.
- Provide guidance to all levels of the organization on matters of Quality including period reviews of the functioning of the Quality System to executive management.
- Coordinate ISO and customer audits. Coordinate FDB and/or FDA inspections if required.
- Establish and maintain processes for measuring and monitoring product quality and quality system processes for providing feedback and assuring continual improvement.
- Lead internal, supplier and external audits.
- Monitor and report Key Performance Indicators (KPI’s) related to company quality objectives.
- A Bachelor’s degree in sciences or a related discipline, or equivalent combination of demonstrated education, training and experience.
- Experience in establishing and maintaining quality management systems.
- Extensive auditing/surveillance experience and training in the Biotech industry.
- Qualified ISO 13485 Lead Auditor is a plus
- Quality related skills and training in relation to communication skills, root cause analysis, and risk assessment, conduct of operations, ISO 13485 standards and other applicable experience and education.
- Experience in quality assurance field within auditing, engineering, as well as inspection, testing etc. (preferred).
- Demonstrated ability in verbal and written English language.
- Proficiency in Microsoft Office Suite.