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.

Open Positions

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

Requirements (Education/Skills)

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: Sr. Quality Engineer

DEPARTMENT: Quality Assurance

POSTING DATE: July 26, 2021

Position Summary

  • 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.

Essential Job Functions

  • 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

POSITION: Business Development Manager

POSTING DATE: August 16, 2021

Position Summary

We are seeking experienced business development professionals with working knowledge of cell & gene therapy research & development, GMP cell manufacturing and CDMO service industry. Successful candidate will hold position of Business Development Manager and will promote the company’s CAR-T express cell manufacturing platform, BioAchive storage for cell therapy manufactured product storage, and its CDMO services to secure new accounts at cell & gene therapy developers and biotechnology companies.

Essential Job Functions

  • Identify and qualify new prospects and business collaboration opportunities by reaching out to decision makers at cell & gene cell therapy developers and providers, domestic and international biotech companies and cell banks.  
  • Contribute to developing and implementing the marketing and sales strategy (e.g., brochures, company presentations, website improvement) 
  • Collaborate with the Company’s senior scientific management to perform feasibility assessments and to convert the opportunities into project proposals 
  • Assist in decisions involving price structure and price negotiations 
  • Develop proposals and assist with the execution of contracts and service agreements
  • Establish and maintain frequent contact with clients through focused client visits and presentations to ensure high levels of client satisfaction on client issues and needs
  • Conduct in-depth research using web resources, scientific forums and other lead sources to identify trendsetting ideas and opportunities 
  • Maintain accurate and current contacts database for accounts (active and targeted); this includes such as account profiles, individual contact details, opportunities and communications 
  • Actively participating at professional meetings and conventions as appropriate 

Qualifications and Skills

•BS, MS or PhD degree in Life Science or Chemistry 

•Strong motivation to expand the existing expertise into business areas 

•Strong interpersonal and presentation skills, good judgment and ability to communicate with a diverse range of professionals from the cell & gene therapy discovery and development community 

•Ability to recognize the needs of the customer and collaborate with scientific management of the Company to develop proposals 

•Understanding the cell & gene therapy discovery and development process is preferred 

•Some travel is required. 

We Offer 

• Competitive Salary & Stock Options

• Medical, Dental & Vision Insurance

• Short and Long Term Disability 

• Life Insurance 

• 401(k) Plan 

• Paid Vacation & Holiday 

• Business Casual Environment.

POSITION: Senior Director/VP, Preclinical Research

DEPARTMENT: Preclinical Research

POSTING DATE: August 18, 2021

Position Summary:  ThemoGenesis has been a leading medical device company that provides automated cellular processing technologies and tools for the cell bank and cell therapy industries. With its newly developed CAR-T express as the new cell therapy manufacturing platform and its flagship product BioArchive as the storage solution for preserving and protecting manufactured cellular product, ThermoGenesis is expanding its services to cell therapy CDMO space. We are seeking an experienced professional to lead our pre-clinical efforts.

Responsibilities and Duties

Reporting directly to the CEO you will translate the company’s preclinical strategic goals into an operational plan and lead your team through the successful execution of these plans.

  • Responsible for the design and oversight of validation studies.
  • Defining the criteria for advancing programs through preclinical development.
  • Defining and executing internal studies and identifying potential external collaborations.

Qualifications and Skills

  • Ph.D. or MD or DVM with 10+ years of relevant field experience.
  • Familiar with immune-oncology, cell therapy, and CAR-T design
  • Proven track record of success in driving discovery research
  • Hands on experiences with vector design, manufacturing, and cellular transfection,
  • Strong interpersonal skills, good judgment, and ability to communicate with a diverse range of professionals from the cell & gene therapy discovery and development community

Position title and level dependent on work experience.

DPCR # 20210818

POSITION:    Staff Accountant

DEPARTMENT:    Accounting

POSTING DATE:  September 16, 2021   

 

Position Summary:  ThermoGenesis is seeking local candidates for our Staff Accountant position.  Reporting to the Assistant Controller, this position is responsible for sales invoices, applying routine revenue recognition rules, check processing, payroll, month-end journal entries, and sales & property taxes.

 

Responsibilities and Duties

  • Apply routine revenue recognition rules to sales invoices.
  • Prepare bi-weekly payroll and payroll related journal entries.
  • Prepare standard month-end journal entries.
  • Prepare monthly bank reconciliations.
  • Prepare other reconciliations as assigned.
  • Prepare sales and used tax, property tax, and other miscellaneous returns.
  • Prepare schedules and analyses for quarterly and annual reviews and audits.
  • Process checks and wires as part of the weekly cash disbursements process.
  • Review aged accounts receivable for accounts to potentially write-off.
  • Follow up on past due invoices.
  • Perform credit checks for new customers.
  • Search for unrecorded liabilities

Education and Skills

  • Bachelor’s degree in accounting or related field required.
  • One to four years of accounting experience
  • Knowledge of basic accounting concepts.
  • Excellent spreadsheet skills and attention to detail
  • Demonstrated proficiency with Windows, MS Word, MS Excel.
  • Ability to always maintain complete confidentiality of accounting information.
  • Ability to work on a detailed level with numerical calculations.
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