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:                       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.

Position Summary: 

  • 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.

Requirements (Education/Skills): 

  • 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.

 

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.
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