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:               Sr. Director of Scientific Affairs

DEPARTMENT:          Scientific Affairs

POSTING DATE:       October 29, 2019

 

Position Summary:

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.

Requirements (education/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.

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: Marketing Specialist

DEPARTMENT: Commercial Operations and Marketing

POSTING DATE: June 3, 2021

ThermoGenesis is looking for a local candidate with the following skills and experience to join the team.

Position Summary:  

This position will work out of our Rancho Cordova office. The Marketing Specialist is an integral part of overall marketing efforts and essential to the development and execution of marketing plans to reach targets from brand awareness to product promotion.

The Marketing Specialist is a competent professional able to evaluate the market and competitive landscape to formulate marketing plans for product introduction and is responsible for supporting creative commercial marketing efforts including digital and online marketing.

The goal is to deliver effective marketing programs that will build brand awareness, company reputation and growth.

Essential Job Functions:

  • Assist in the development and execution of market programs and deliverables including targeting, messaging, collateral development, and global sales.
  • Collaborate with internal product managers and external agencies to drive the completion of marketing materials, including flyers, solution brochures, website content, white papers, videos, webinars, promos, sales tools, social media communications, and customer presentations.
  • Responsible for marketing activities at trade-shows including annual evaluation. 
  • Leverage analytics to determine the effectiveness of marketing programs based on KPI and ROI marketing metrics. Regularly track marketing program results; develop and present metrics dashboards and recommendations for plan improvements.
  • Lead the sustaining marketing activities for existing campaigns, including updating marketing materials, web pages, emails, newsletters, and other communications, as necessary. 
  • Create, implement, and optimize appropriate marketing content across digital channels, including web, video, social media, paid search and display advertising.
  • Assist with the development of sales tools for commercial teams, technical training, and customer-facing materials in collaboration with product management, R&D, and commercial teams.
  • Execute tactical projects to achieve KPI, revenue targets and other annual operating plan objectives.
  • Conduct market research, competitive analysis and analyze data to identify and define market need.
  • Manage and maintain Customer Relationship Management (CRM) data and platform.

Requirements (Education/Skills):  

  • Bachelor’s degree in life sciences, biology, marketing, business administration, or communications.
  • A minimum of 3 years of experience with a proven track record of accomplishments in marketing/marketing communications.
  • Previous experience executing marketing communications is required.
  • Experience writing technical content with the ability to develop messaging for sales and customer-facing materials.
  • Must be detail-oriented – must have the ability to identify and resolve problems and complete tasks with attention to detail.
  • Strong business acumen, marketing experience, and customer focus are essential.
  • Digital marketing understanding in various channels and digital performance metrics, SEO and Google AdWords, and eCommerce.
  • Understanding of analytics metrics and how to use them to inform plan improvements.
  • Able to act in a highly autonomous manner and address complex programs with high corporate visibility.
  • Proven track record of managing multiple projects with a demonstrated ability to meet deadlines and stay within budget.
  • Excellent interpersonal skills with the ability to gain consensus and facilitate decision-making processes within a fast-paced environment.
  • Proficient in Excel, Word, and PowerPoint
  • Lab experience is a bonus.
  • Global market experience in medical device industry is a plus.

POSITION: Buyer

DEPARTMENT: Supply Chain

POSTING DATE: June 3, 2021

Position Summary:  ThermoGenesis is looking for a local candidate who under general supervision coordinates activities involved with procuring goods and services such as raw materials, parts and supplies by preparing purchase orders or quote requests, reviewing requisitions, and maintaining procurement records. Responsible for all duties related to purchase order entry and post-entry supply chain tracking.  Interacts with suppliers, to maintain optimal pricing and on time delivery. Will exercise a degree of independence.

Responsibilities and Duties

  • Purchase MRO materials and other non-Inventory requisitioned materials.
  • Facilitate return of discrepant material to assigned suppliers and communication of non-conformances.
  • Procure materials using the ERP system/Master Schedule to support established production plan and minimize material shortages.
  • Manage and plan purchased parts and issue PO’s as necessary, ensure timely supplier delivery of ordered parts and resolve issues related to parts & suppliers.
  • Maintain accurate supplier files and associated Vantage ERP information.
  • Ability and desire to multitask and prioritize multiple duties and deadlines.
  • Ability to follow through with minimal direction.
  • Maintains procurement records such as items or services purchased costs, delivery, product quality or performance, and inventories.
  • Ability to prioritize and complete tasks in a fast-paced environment.

Qualifications and Skills

  • AA/AS or equivalent experience
  • 1-2 years of experience working within purchasing as Buyer.
  • Experience with ISO-9001 or ISO-13485 registered manufacturing company is preferred but not required.
  • Has knowledge of commonly used practices, procedures used in planning and purchasing activities.
  • Familiarity with utilizing automated ERP systems and databases.
  • Relies on experience and judgment to plan and accomplish goals.
  • Able to communicate effectively in English and follow written procedures.
  • Basic understanding and utilization of Microsoft Office applications.
  • Ability to plan and multitask effectively.

POSITION: Associate Scientist – Cell Processing

DEPARTMENT: Scientific Affairs

POSTING DATE: June 25, 2021

Position Summary: ThermoGenesis is looking for a local candidate who will be responsible for designing, optimizing, and executing scientific protocols, data analysis, and writing and submitting final reports in addition to providing scientific support and training.

 

Responsibilities and Duties

• Design and execute laboratory experiments, tests, and studies in support of new product development and product improvement.

• Use cell separation technologies to conduct cell isolation and preparation from blood, bone marrow, apheresis products and other tissues in accordance with approved workflow and safety protocols.

• Perform cell analysis including, but not limited to, cell counting, flow cytometry, and cell culture.

• Review, analyze, and summarize data and provide input to assist in development of new technologies and products.

• Maintain mammalian cell cultures

• Instrument set-up and preparations, maintenance, troubleshooting and operation

• Assist in training of new hires

• Prepare written reports and PowerPoint presentations of the study outcomes.

• Review outcomes and findings with Scientific Affairs management.

• Adhere to procedures, instructions, and policies in compliance with GLP and cGTPs.

• Perform laboratory cleaning, equipment cleaning and maintenance.

• Assist with maintenance of calibration of identified laboratory instrumentation

• Order laboratory supplies and maintain required inventory.

 

Work performed will support product improvement and new product development including release testing. This position is M-F 8-5 pm but flexibility and overtime may be required to support development activities and project timelines.

Qualifications and Skills

• B.Sc. in a biological science with a minimum of 3 years of professional experience (ideally MS). •

• Laboratory experience in mammalian cell processing and analysis is preferred

• A background in immunology and/or cell therapy is preferred.

• Experience with flow cytometry and cell characterization techniques are highly desired.

• Laboratory documentation, reports and correspondence experience required

• Hands on experience with aseptic technique is required

• Mammalian cell culture experience is a plus

• Experience in safe manipulation of samples derived from blood and blood products/tissues in accordance with AABB and corporate protocols.

• Strong proficiency in analysis of data sets and troubleshooting

• Experience in optimization of protocols

• Experience in documenting, organizing, and presenting scientific data

• Effective interpersonal and communication skills (oral and written).

• Ability to read, interpret documents such as operating and maintenance instructions, procedure manuals

 

Personal Qualities

· Highly detail oriented with special attention to quality.

· Ability to multitask and handle multiple responsibilities simultaneously ; able to prioritize.

· Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment.

· Ability to work independently and as part of a team.

· Highly tolerant and respectful of all members of our team.

· Strong problem-solving skills with desire to improve upon established processes.

POSITION: Assistant Scientist – Cell Processing

DEPARTMENT: Scientific Affairs

POSTING DATE: June 25, 2021

 

Position Summary: ThermoGenesis is looking for a local candidate who will assist with executing scientific protocols, data analysis, writing and submitting final reports and will be responsible for the maintenance of laboratory facilities, equipment, and supplies.

 

Responsibilities and Duties

• Execute laboratory experiments, tests, and studies (studies) under supervision in support of new product development.

• Use cell separation technologies to conduct cell isolation and preparation from blood, bone marrow, apheresis products and other tissues in accordance with approved workflow and safety protocols.

• Review, analyze, and summarize data with guidance and provide input to assist in development of new technologies and products.

• Assist with maintenance of mammalian cell cultures

• Assist with instrument set-up and preparations, maintenance, troubleshooting and operation

• Review outcomes and findings with Scientific Affairs management.

• Assist with preparing written reports and PowerPoint presentations of the study outcomes.

• Adhere to procedures, instructions, and policies in compliance with GLP and cGTPs.

• Communicate with other teams to improve product and work-flow practices.

• Perform laboratory cleaning, equipment cleaning and maintenance.

• Assist with maintenance of calibration of identified laboratory instrumentation

• Order laboratory supplies and maintain required inventory.

 

Work performed will support product improvement and new product development including release testing. This position is M-F 8-5 pm but flexibility and overtime may be required to support development activities and project timelines.

Qualifications and Skills

• B.Sc. in Biological Sciences

• Cell biology, Immunology preferred

• 1+ year experience within the biological and/or pharma industry preferred

• Laboratory documentation, reports, and correspondence

• Hands on experience with aseptic technique

• Experience working with blood and blood products, isolation of PBMCs and cell selection is a plus

• Mammalian cell culture experience is a plus

• Effective interpersonal and communication skills (oral and written).

• Ability to read, interpret documents such as operating and maintenance instructions, procedure manuals

 

Personal Qualities

· Highly detail oriented with special attention to quality.

· Ability to multitask and handle multiple responsibilities simultaneously ; able to prioritize.

· Demonstrated strong work ethic, curiosity to learn, ask questions and contribute in a fast-paced collaborative environment.

· Ability to work independently and as part of a team.

· Highly tolerant and respectful of all members of our team.

· Strong problem-solving skills with desire to improve upon established processes.

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: Operation Analyst and Master Planner

DEPARTMENT: Manufacturing Operations

POSTING DATE: July 27, 2021

Position Summary

Responsible for maintaining records of inventory and the quantity and location accuracy of individual products in warehouses and off-site locations; cycle counting program which includes counting all types of products of varying degrees of value; leading Receiving, Shipping and Cleanroom replenishment functions; produce and maintain key performance metrics for these areas.

Essential Job Functions

  • Loading Forecast and Running MRP
  • Change Order Review 
  • Part Entry and Maintenance in ERP system
  • Freight Bill Coding
  • Sterile Shipments 
  • Oversight of Shipping, Receiving, Kitting and Stock replenishment functions
  • Perform all Inventory transactions in ERP system
  • Assist as required in shipping and receiving
  • Coordinate completion of timely stock transfers, and inventory audits to support an accurate inventory management system.

Qualifications and Skills

  • HS Diploma required, BA/BS degree in Business, Operations, Supply Chain or related field or equivalent a plus
  • 3-5 years of experience directly related to production planning, inventory, and warehouse activities
  • Strong understanding and knowledge of ERP/MRP systems. Knowledge of EPICOR Vantage a plus. 
  • Proficient in MS suite of software such as Word, Power Point, Excel, Access, and Outlook
  • Experience in ISO 9001 and/or 13485 requirements
  • Strong communication skills both written and verbal
  • Effective planning, scheduling, time management and prioritization skills
  • Ability to effectively interface and negotiate with other key functions within the organization
  • Flexibility to pivot on changing priorities. 
  • Skilled in communication, leadership, and ability to lead activities in the areas of responsibility
  • Ability to work under pressure and adhere to deadlines and target dates.
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