Join the Innovation of Cell-Based Automated Technologies
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: Sr. Director of Scientific Affairs
DEPARTMENT: Scientific Affairs
POSTING DATE: October 29, 2019
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.
Essential Job Functions:
- 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 CART-Xpress 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.
- 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.
POSITION: Research & Development Software Engineer
DEPARTMENT: Research & Development
POSTING DATE: March 23, 2021
Position Summary: ThermoGenesis is looking for a local candidate who will perform professional work in research, design, development and testing of software applications for medical devices.
General areas of job responsibilities will include software design, software development, software testing and bug fixes, writing testing documents, and maintaining software applications for medical devices written in Delphi and Borland C++ Builder.
Responsibilities and Duties
- Responsible for software design, development, coding, testing, bug fixing and maintaining of applications for medical device.
- Independently evaluates, selects, and applies standard software engineering practices and procedures to create software design concepts that satisfy or exceeds product requirements and/or make major and minor modifications and enhancement to existing software designs.
- Plans and schedules work assignments and tasks in coordination with overall project objectives.
- Meet project design and documentation goals within predetermined time frames. Generate complete, concise documentation of the software requirement specifications, software design specification, and detail design including software coding.
- Develop testing & validation plan and either conduct or direct other personnel in carrying out such plans. Ability to analyze data and results, reporting the observations including anomalies, and making sound technical conclusions.
- Software Engineer will own and author all software development documentation:
SAS Software Architecture Specification
SDD Software Design Description
SDP Software Development Plan
SDS Software Design Specification
SLOC Software Level of Concern
SRS Software Requirements Specification
SVP Software Verification Plan
To perform the essential responsibilities of this position the person must have possess the following qualifications, skills and training:
- Bachelor’s or Master’s degree in software engineering or related discipline and 3 to 5 years of experience in software development with emphasis on embedded system and medical devices.
- Ability to create clear, concise software documentation, including design specifications, detail design, code related documents, and tests plan.
- Thorough knowledge of computer development systems and tools, with emphasis on PC platforms, Pascal and C/C++ Programming Languages.
- Understanding and knowledge of Microsoft’s Windows Operating system; TCP/IP and other networking protocols and GUI design.
- Good working knowledge of creating and maintaining application using these.
Preferred and Desired Experience:
Knowledge of and experience with the following Software packages:
- Experience in writing code in Pascal and C++ using Borland Delphi and C++ Builder or other IDE CVS or other version control software Bugzilla or other bug tracking software
- Knowledge and experience with software design control procedures applicable to medical device manufacturing company.
- Knowledge and experience with embedded software (firmware) design and development standards.
- Knowledge or conversant with assembly language programming. Ability to work in a fast-paced, dynamic, routinely changing environment with agility and adaptability to handle changing tasks, projects, and priorities with minimal “down” or “ramp up” time.
POSITION: Director of Regulatory Affairs
DEPARTMENT: Regulatory Affairs
POSTING DATE: March 31, 2021
ThermoGenesis is looking for a local candidate with the following skills and experience to join the team.
- Oversight and Management the Regulatory Affairs function
- Prepare and maintain filings to ensure compliance with regulations worldwide.
- Provide regulatory strategy and guidance during design and development throughout product lifecycle.
Essential Job Functions:
- Communicating regulatory strategy at the corporate level.
- Manages and executes regulatory strategies for earliest possible approvals of the company’s regulatory applications at all stages of development (e.g., design phase 1 through phase 4 and post launch, regulatory assessment/plan, technical files, distribution regulatory strategies for global markets).
- Provides guidance on interpretation and application of global medical device regulations (US FDA, EU MDR).
- Ensure compliance with global regulatory requirements, including submissions, registrations, product listings, EC certificate maintenance, foreign registration maintenance, adverse event reporting, reporting to regulatory agencies and distributors.
- Develops and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.
- Primary point of contact for regulatory agencies.
- Interacts with and manages regulatory agency inspections.
- Provides support during partner and customer audits.
- Ensures timely preparation of organized and scientifically valid applications.
- Provides expertise in translating regulatory requirements into practical, workable plans.
- Selects, develops and evaluates, counsels’ personnel to ensure the efficient operation of the function.
- Prepare, communicate, and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the regulatory department.
- Develops positive and proactive approaches to regulatory compliance.
- A bachelor’s degree in sciences or a related field.
- 10+ years of experience with FDA regulations and filings (IDE, 510(k), DMF, Annual Report), OUS product licensing, MDR/MDD, design dossier, technical file, vigilance reporting, ROHS, application and use of European harmonized standards.
- CBER and CDRH experience required.
- Ability to review and analyze documents as they apply to manufacturing, quality systems and regulatory compliance.
- Inspection, surveillance, audit experience and training.
- ISO 13485 and 21 CFR 820 Quality compliance, UDI requirements, risk management, design controls.
- Provide clear and direct communication verbally and in writing.
- Proficient in the use of business systems such as Microsoft product (Word, Excel, Access, PowerPoint, Project) other PC oriented business platform software programs.