Job Opportunities

Join us as we revolutionize the field of clinical microbiology!

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Job Title: Senior Development Analytical Chemist

Position Summary

The Senior Development Analytical Chemist (SDAC) will be responsible for providing broad chemistry leadership for the company in all matters of research, development, optimization and trouble-shooting for manufacturing.  Initially the SDAC will work closely with the assay development and engineering teams to assure that all reagents formulations and stability related to antibiotics and FISH reagents, as well as reagent packaging configurations are optimized.

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Principal Responsibilities and Duties:

  • Support chemistry-focused technology development
  • Evaluate reagent formulations/stability and consumable compatibility, assess potential degradation during manufacturing processes, identify problematic areas, determine corrective actions and develop workable solutions
  • Develop stability strategies and studies for all reagents and consumables
  • Develop reagent performance study plan, and assess reagent performance and consistency
  • Develop and initiate reagent quality studies
  • Suggest vendors and participate in vendor qualification
  • Develop package strategy for reagents
  • Work cross-functionally with all departments to assure success of reagents and packaging
  • Develop proprietary packaging to assure reagent business capture, blocking competition
  • Support development with relevant documentation in a regulated (FDA) environment as required
  • Provide technical updates to project leadership for all ongoing work assignments
  • Achieve targeted timelines and milestones

Qualifications:

Formal Training/Education:

  • Advanced degree in Chemistry (Analytical) or Chemical Engineering

Experience and required skills:

  • A minimum of 10 years relevant experience
  • Clinical microbiology  and/or Pharmaceutical Chemistry experience preferred
  • Lyophilized and onboard reconstitution of reagents including antibiotics
  • Fluorescent reagent experience preferred
  • Experience using HPLCs (must), Mass Spec, and other analytical instrumentation
  • Candidate excels in in a rapidly changing environment and is comfortable working in a cross-functional teams
  • Life sciences/automated medical laboratory instrumentation experience

Job Title: Research Associate, Assay Development

Position Summary

Accelerate Diagnostics seeks a Research Associate for assay development to help bring the company’s innovative clinical microbiology technology to market. This technology extracts live bacterial and fungal pathogens directly from clinical specimens, counts the number of live organisms, identifies, and then characterizes resistance phenotypes in less than 8 hours. This revolutionary approach eliminates the need for enrichment and isolation significantly changing the paradigm that has driven the market for the last century.

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Principal Responsibilities and Duties:

  • Execute experiments on Accelerate’s prototype instruments
  • Run conventional bacterial culture based assays
  • Prepare buffers, growth media, other reagents, and antibiotic stocks as required for experimentation
  • Assist in new assay development and experimentation

Qualifications:

Formal Training/Education:

  • BS in Microbiology, Biology, or related science field preferred.

Experience and required skills:

  • BS in a relevant field; on-the-job practical experience will be considered in addition to degree achievement
  • 3+ years of clinical experience preferred in a research and/or development environment.
  • Excellent aseptic technique and good organizational skill
  • Microbiological culture and testing experience
  • Exceptional pipette and liquid handling skills
  • Excellent verbal and written communication skills.
  • Experience working within a design control environment is desirable.
  • Computer skills including Windows, Word, Excel, and Powerpoint

Job Title: Data Scientist / Machine Learning

Position Summary:

The Data Scientist position will mine results from time-lapse digital imaging of individual single live bacterial cells under antibiotic stress to develop population models and algorithms for susceptibility classification.  The company’s culture free clinical microbiology technology works directly from clinical specimens, extracting live bacterial and fungal pathogens.  It counts the number of live organisms, identifies, and then monitors susceptibility of bacteria reporting results in less than 8 hours.  The revolutionary approach eliminates the need for enrichment and isolation significantly changing the paradigm that has driven the market for the last century.  Analysis of live-cell populations requires initiative, intellectual curiosity, and diligent observation for insight into organism behavior.   Consequently, the successful candidate will use his or her judgment to discern material scientific observations that drive achievement of development milestones from those that are theoretically interesting.  The ideal candidate will be self-motivated, curious who enjoys independent work in a fast changing high-pressure environment.

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Principal Responsibilities and Duties: 

  • Develop multi-parametric algorithms to correlate bacteria identification and susceptibility assay data with gold standard methodology.
  • Elucidate relationships between data patterns and microscopic images of live bacteria under control and test condition.
  • Conduct advanced statistical analysis and create reports and visualization tools to illustrate statistical significance of experimental results and identify trends
  • Work with the laboratory staff to help quickly detect and identify experimental problems and failures with statistical analysis
  • Manage data stream generated by HPC cluster through efficient reporting of results
  • Develop statistical methods and machine learning for predictive analysis to decrease time to result

Formal Training/Education:

  • Post-graduate education in machine learning, applied mathematics, statistics and/or computer science.

Experience and Required Skills:

  • Experience with data and image  analysis
  • Experience with advanced statistics, data mining, machine learning methods
  • Knowledge of image processing algorithms and related data analysis and visualization
  • Experience in scientific programming in MATLAB,  JAVA, C#, or equivalent.
  • Excellent verbal and written communication skills
  • Experience and proficiency in statistical programs and image processing software such as ImageJ or equivalent
  • Knowledge of object-oriented data structures
  • Experience with SQL database queries

Job Title: Senior Account Executive

Position Summary:

This position requires expertise in both strategic account management as well as tactical components of selling.  From a strategic perspective, the incumbent will gather salient information from a variety of sources and will formulate and execute important long term account plans. From a tactical perspective, the incumbent will engage the respective buying influencers in a credible and professional manner, and by employing the necessary selling skills will be proficient at delivering revenues and profits to the company.

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Principal Responsibilities and Duties:

  • Strategic positioning of the company as well as its products.
  • Interface with KOL network.
  • Interface with key accounts.
  • Achieve assigned sales targets.
  • Prospecting and developing new client relationships within a defined geography or market.
  • Consulting with clients on business issues.
  • Developing proposals and delivering strategic sales presentations.
  • Making recommendations for new products, line extensions, or enhancements.
  • Resolving contractual or logistical issues with customers.
  • Provide input to the Marketing Plan.
  • Assist with the building of credible metrics around total and available markets.
  • Build and maintain hospital/customer database in the designated territory.
  • Assist with development and deployment of go to market strategy.
  • Complete and maintain analyses of macro market conditions.
  • Complete and maintain analyses of competitive elements.

Qualifications:

Formal Training/Education:

  • BA, BS or equivalent in a directly related discipline. Advanced degree preferred
  • 10+ years of industry related experience (microbiology preferred).

Experience and Required Skills:

  • Au fait with diagnostic laboratory dynamics.
  • A mature, professional and credible demeanor.
  • An aptitude for scientific understanding and technical delivery.
  • Has successfully developed and executed successful long term account management strategies.
  • Demonstrated success in creativity and independent thought.
  • Demonstrated sales success at the senior/key account level.
  • Expert knowledge and application of strategic as well as tactical selling principles.
  • Experience reading and analyzing medical journals and publications.
  • Thorough working knowledge of Microsoft or Apple applications.
  • Working expertise in business modeling on Excel.
  • Ability and willingness to travel.
  • Outstanding written and oral communication skills.
  • Superior business and negotiation skills.
  • Extensive industry contacts.

Job Title: Purchasing Manager

Position Summary:

The Purchasing Manager position will join Accelerate Diagnostics’ finance and operations teams in building a foundation for global purchasing to support the manufacturing of the Company’s flagship diagnostic system.  The Purchasing Manager will work closely with accounting, finance, and operations to implement purchasing processes/systems, qualify and negotiate purchase agreements with key vendors, and execute purchasing transactions.

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Principal Responsibilities and Duties:

  • Scope and co-lead implementation of planning, purchasing, inventory and receiving systems
  • Build product Bill of Materials and maintain such in the company’s ERP system
  • Help implement quality-related elements of the company’s ERP system
  • Negotiate and close purchase/supply agreements
  • Lead qualification of key vendors and maintain approved vendor list
  • Manage company purchase cards program
  • Assist in Sunshine Act compliance and reporting
  • Assure compliance with Sarbanes-Oxley purchasing controls
  • Transact purchase orders

Qualifications:

Formal Training/Education:

  • Bachelor’s degree required, MBA or advanced degree preferred
  • A minimum of 5 years relevant experience
  • 3-5 years medical diagnostics / ISO13485 purchasing industry experience preferred

Experience and Required Skills:

  • Strong verbal and written communications and presentation skills
  • Proven negotiating skills
  • ERP / MRP experience
  • Strong familiarity with Lean Manufacturing
  • Exceptional organization skills and attention to detail
  • Proficiency with MS Word, Excel, and PowerPoint

Job Title: Head of Financial Planning & Analysis

Position Summary:

The Head of Financial Planning & Analysis will lead the supply and analysis of key decision making information for the enterprise.  The position will require an experienced and talented professional to lead formational financial planning infrastructure projects and the accurate execution of forecasts, plans, and trade-off analyses.

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Principal Responsibilities and Duties:

  • Execute monthly forecasting of full financial statements and conduct budget variance analysis for team reviews.
  • Lead financial systems strategy and maintenance.
  • Identify, source, implement, and support financial planning solution.
  • Lead annual budget and long-range planning process including the management of a master planning model and presentation set for management and Board review.
  • Conduct make/buy and costing analyses.
  • Support cost-reduction programs through supplying needed analysis for trade-off decisions.
  • Support management in the preparation of investor presentations, earnings calls, and related investor materials.
  • Facilitate financing and commercial logistics.
  • Assist in the preparation of Management Discussion & Analysis sections of SEC filings.
  • Provide general financial support and leadership to the company.

Qualifications:

Formal Training/Education:

  • Bachelor’s degree required, MBA preferred
  • A minimum of 5 years finance experience
  • 4-5 years of diagnostics experience preferred
  • A minimum of 3 years public company experience required

Experience and Required Skills:

  • Expert Excel and financial modeling/analysis skills
  • Proven written/verbal communicator
  • Sophisticated understanding of US GAAP accounting and financial statements
  • Experience leading annual budgeting/financing process
  • Strong cash and accrual basis forecasting skills

Job Title: Head of European Commercial Operations

Position Summary:

The Head of the European Commercial Operations (ECO) will join Accelerate Diagnostics’ leadership team in providing vision, leadership, structure, and rigor to ensure that the company has the people, plans and systems in place to commercialize the company’s innovative microbiology diagnostic systems in Europe.  He/she will attract, develop and lead a premier organization, and as a key member of the executive team, will also participate in the development and implementation of the overall strategic direction of the business.

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Principal Responsibilities and Duties:

  • Display and practice a visible, open, and motivated leadership style, ensuring that all employees understand the culture required fulfill the company mission.
  • Develop trust, credibility, and integrate into the existing team environment in a collaborative manner.
  • Foster a robust culture of action, communication, collaboration and high-performance.
  • Coordinate primary and secondary research and distill into effective pricing, organizational, positioning, branding, and other sales and marketing strategies.
  • Lead the commercial roll-out of the company’s microbiology platform in Europe.
  • Develop and manage the product logistics and support plan for the organization.
  • Establish relationships with key opinion leaders, clinical trial sites and customers.
  • Establish Medical and Scientific Advisory Boards in Europe.
  • Manage distributor strategy and relationships.
  • Develop and adhere to annual budgets.
  • Participate in long range strategic business planning.
  • Monitor scientific, medical and industry trends, collaborating with the executive team to identify new business opportunities.
  • Work closely with R&D teams to guide product development – providing insights re European customer requirements.

Qualifications:

Required Personal Attributes:

  • A leader with an ability to inspire trust and confidence in others.
  • A balance of entrepreneurship and drive with analytical capability and respect for process.
  • A propensity to be resourceful and energetic.
  • Unquestionable in his/her integrity.
  • Cross-cultural sensitivity and the ability to work effectively in a global environment.
  • A team leader/builder who leads by example.
  • A collaborator who knows how to establish effective cross-functional relationships.
  • An assertive, driven and hands-on individual who is intrinsically motivated.
  • Credible presence, with exemplary communication and interpersonal skills.
  • Exceptional verbal and written communications skills.
  • Outstanding presentation skills.
  • Sound financial and analytical acumen.
  • Perseverant and passionate about making a tangible difference in the lives of patients.
  • Willingness to travel.
  • Broad network of industry contacts.
  • Knowledge of CRM processes and the ability to leverage technology to improve personal and team efficiency.
  • Proficiency with MS Word, Excel, and Powerpoint.

 Formal Training/Education:

  • An undergraduate degree in a relevant scientific or business discipline is required.
  • MBA preferred.

Experience and Required Skills:

  • Commercial management within the in vitro diagnostic industry.
  • A strong track record of driving substantial revenue growth.
  • Proven strategic as well as execution abilities.
  • Demonstrated success hiring effective teams and consistently meeting performance targets.
  • Demonstrated track record of driving market conversions.
  • Experience in working with C-Suite, economic buyers and key opinion leaders.
  • A history of selling ideas persuasively and positively influencing the opinions of stakeholders.
  • Experience in market development for novel technologies.
  • Experience in building scalable organizations.
  • Experience in navigating the regulatory process in key markets.

Job Title: Clinical Trials Manager

Position Summary:

Accelerate Diagnostics seeks an experienced and talented clinical trials manager to work with our regulatory, quality, and scientific affairs leadership in the design and conduct of clinical trials for our flagship diagnostic platform.

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Principal Responsibilities and Duties:

  • Provide key support to multiple investigators in planning and coordination of study protocols, and the establishment of operating policies and procedures.
  • Assist in project planning, and ensure that pre-established work scope, study protocol, and regulatory requirements are followed.
  • Coordinate site technical support and training.
  • Facilitate necessary IRBs and prevent unnecessary delays in protocol approval. Otherwise coordinate, submit, and maintain paperwork for protocols to ensure compliance.
  • Prepare for site visits and audits.
  • Work with collaborators to assess needs and manage the resolution of those needs.
  • Develop methods, tools and strategies to improve protocol coordination.
  • Ensure successful conduct of clinical research protocols that adhere to best practices and achieve maximum scientific information.
  • Act as principal administrative liaison for the project including but not limited to serving as data manager for studies, managing clinical research associates, data collection, report outs to internal and external stakeholders and coordinating visits.
  • Establish and implement SOP’s and regulatory documentation for Clinical Operations.

Qualifications:

 Formal Training/Education:

  • Bachelor’s degree required, advanced degree and/or Clinical Research Professional Certification preferred.
  • A minimum of 5 years relevant experience
  • 3-5 years medical diagnostics trials experience preferred

Experience and Required Skills:

  • Strong writing skills.
  • Excellent organizational skills and ability to prioritize tasks. Detail oriented, self-motivated, ability to work independently and in a team-oriented setting.
  • Ability to effectively communicate verbally and in writing with investigators and other study stakeholders.
  • The candidate should have excellent computer skills and leverage technology to improve efficiency and solve problems.
  • Experience in both 510k and PMA oriented clinical trial design and execution.
  • Knowledge of regulation of in vitro diagnostics devices (IVDs) including FDA guidance on use of leftover specimens
  • Experience in both 510k and PMA oriented in vitro diagnostic device clinical trial design and execution.
  • Mastery of GCPs and ICH Guidelines.
  • Experience with clinical trial data management software.

Job Title: Clinical Trials Associate

Position Summary:

The Clinical Trials Associate will join Accelerate Diagnostics at an exciting and important stage of its development to support the conduct of clinical trials for its flagship diagnostic system.  The position will report to our Clinical Trials Manager and work closely with regulatory, scientific affairs, engineering, and quality staff and leadership.

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Principal Responsibilities and Duties:

  • Coordinate and assist in setting up new clinical trials sites including: training, instrumentation installation, kit supply logistics, sample flow management, database set-up, and other activities as required.
  • Provide oversight and support to all clinical trial sites.
  • Periodic travel to clinical trial sites for site qualification, initiation, interim monitoring and closeouts.
  • Proactively monitor study status and develop and implement a risk mitigation strategy as needed to ensure the study progresses according to plan.
  • Ensure compliance with relevant regulations and guidelines.
  • Organize and manage internal team meetings, investigator meetings and other trial-specific meetings.
  • Actively participate in data review and the preparation of reports and presentations
  • Maintain a working knowledge of all relevant functional area SOPs and ensure adherence in the conduct of work-related activities.
  • Prepare for and participate in sponsor and FDA audits
  • Performs other additional job related duties as required.​

Qualifications:

 Formal Training/Education:

  • Bachelor’s degree required
  • A minimum of 3 years relevant experience
  • Medical diagnostics trials experience preferred

Experience and Required Skills:

  • Strong writing skills.
  • Excellent organizational skills and ability to prioritize tasks. Detail oriented, self-motivated, ability to work independently and in a team-oriented setting.
  • Ability to effectively communicate verbally and in writing with investigators and other study stakeholders.
  • The candidate should have excellent computer skills and leverage technology to improve efficiency and solve problems.
  • Knowledge of GCPs and ICH Guidelines.
  • Experience in both 510k and PMA oriented clinical trial design and execution.

Job Title: General Counsel

Position Summary:

Accelerate’s General Counsel will provide day-to-day legal support and work with company leadership to set strategic direction.  Accelerate as an intellectual property rich public company provides a unique opportunity for a legal professional to make a high impact in business poised to revolutionize microbiology.

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Principal Responsibilities and Duties:

  • Preparation, negotiation, and review of material transfer agreements, supply agreements, non-disclosure agreements, license agreements, contract research agreements, consulting agreements, customer contracts, distribution agreements, option agreements, and other contracts as required.
  • Preparation and review of routine SEC filings including but not limited to 8-Ks, Form 3s and 4s, 10-Qs, 10-Ks, 14a’s.
  • Keep abreast of applicable laws that may impact the business and provide counseling and guidance to ensure compliance.
  • Preparation and review of investment filings and associated correspondence with the SEC.
  • Manage external law firms for specialized legal work as required.
  • Support the company in matters of legal strategy.
  • Manage the company’s legal budget.
  • Manage the company’s intellectual property portfolio.

Qualifications:

 Formal Training/Education:

  • Juris Doctor degree required
  • Admitted to and in good standing before the bar of Arizona

Experience and Required Skills:

  • Minimum of 10 years of experience in the service of a corporations or as in-house counsel within corporations required
  • Minimum of 5 years public company legal support experience
  • Excellent verbal and written communication skills
  • Familiarity with Delaware incorporation laws
  • Ability to build long and lasting relationships across business functions and among both internal and external stakeholders.
  • Familiarity with FDA regulatory framework
  • Experience drafting and reviewing complex agreements
  • Familiarity with human resource law, immigration law, litigation, and corporate tax law
  • Strong background in intellectual property law.
  • Aptitude with Microsoft Word, Excel, Powerpoint, and Sharepoint

Job Title: Patent Attorney

Position Summary:

Accelerate’s Patent Attorney will manage the company’s intellectual property portfolio.  Specifically this role will require the maintenance and as required the retirement of existing intellectual property, evaluation and execution of new intellectual property opportunities, and support in the defense of the company’s portfolio.  In Accelerate’s high growth and collaborative environment the Patent Attorney will get broad exposure to and participation in the direction of the business.  The ideal candidate will be a seasoned patent professional with both life science specific knowledge and deep legal experience.

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Principal Responsibilities and Duties:

  • Conduct patentability / prior art / freedom to operate searches
  • Develop strategies for US and foreign patent portfolios and related R&D platform technologies.
  • Patent preparation and prosecution
  • Establish a framework for the protection of trade secrets
  • Support licensing activities
  • Ensure protection of intellectual property through the drafting, negotiation, and analysis of supply agreements, clinical trial contracts, material transfer agreements, and other agreements
  • Assist in the evaluation of potential infringers of the company’s intellectual property
  • Guide onboarding and exiting processes to assure confidentiality and security of the company’s trade secrets and other confidential information.

Qualifications:

 Formal Training/Education:

  • Juris Doctor from an accredited law school
  • Member in good standing of at least one state bar
  • Registration to practice before the U.S. Patent and Trademark Office
  • Science focused Bachelor’s degree preferred

Experience and Required Skills:

  • Minimum of 10 years of relevant patent attorney experience
  • Minimum of 5 years medical device or related life science industry experience
  • Excellent verbal and written communication skills
  • Ability to build long and lasting relationships across business functions and among both internal and external stakeholders
  • Experience drafting and reviewing complex agreements
  • Aptitude with Microsoft Word, Excel, Powerpoint, and Sharepoint
  • Demonstrated ability to collaborate, as well as work independently, balancing competing priorities to achieve results in a fast-paced environment

Job Title: Consumables Manufacturing Quality Engineer

Position Summary:

The Consumables Manufacturing Quality Manager will join Accelerate Diagnostics’ operations team to lead manufacturing quality for consumables run on the Company’s flagship diagnostic system.  The Consumables Manufacturing Quality Manager will work closely with Development to establish outgoing and incoming quality-control processes for consumables; then use those processes to produce consistently high-quality consumable kits at product launch and beyond.

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Principal Responsibilities and Duties:

  • Collaborate with Development to establish critical reagent product specifications
  • Establish initial lot-testing and ongoing stability testing requirements for key consumables
  • Establish and maintain all elements of Accelerate’s incoming QC laboratory for consumable materials
  • Create work instructions for consumables receiving, quality control and manufacturing areas
  • Scope and co-lead introduction of electronic device history records (eDHR’s) to QC and kit-pack areas
  • Lead, manage and train IQC team, incorporating Lean Manufacturing principles
  • Co-manage (with supplier quality) timely completion of validations at key consumable suppliers
  • Help implement quality-related elements of the company’s ERP system
  • Co-lead and validate fully barcode-driven material flow in consumables/kit-pack areas

Qualifications:

 Formal Training/Education:

  • Bachelor’s degree (minimum) in chemistry/life-sciences, with at least 5 years of relevant experience
  • 3-5 years medical diagnostics / ISO13485 industry experience preferred

Experience and Required Skills:

  • Solid experience with lean concepts/tools such as Value Stream Mapping, Kanban and Kaizen
  • Exceptional leadership skills, organization skills and attention to detail
  • Strong verbal and written communications and presentation skills
  • Familiarity with ERP / MRP systems
  • Team player with passion, customer focus, a demonstrated sense of urgency to resolve issues as they arise, and the ability to handle multiple priorities in a fast-paced environment

Job Title: Biostatistician

Position Summary:

Accelerate Diagnostics seeks an experienced and talented Biostatistician to provide statistical and strategic support related to clinical development plans, study designs, planning and execution of data collection and analysis of data from analytical and clinical studies, for our flagship diagnostic platform.

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Principal Responsibilities and Duties:

  • Designs clinical trials with appropriate statistical methods and sample size to support regulatory submissions in the US and ROW
  • Writes data analysis plans and programs tables, listings and figures for clinical study reports
  • Collaborates in the preparation and review of study protocols and case report forms (CRF) for clinical trials
  • Develops data management plans and serves as data manager for studies, manages all aspects of data collection and reporting to internal and external stakeholders
  • Develops clinical trial database, data specifications, including CRF design, user requirements, edit rules & checks, query logic and data validation plans
  • Monitor clinical data quality and ensure readiness for lock/unlock and freeze/unfreeze as appropriate for statistical review and final database lock
  • Develop methods, tools and strategies to improve data capture and analysis

Qualifications:

 Formal Training/Education:

  • Bachelor’s degree required, advanced degree and/or Biostatistics preferred.
  • A minimum of 5 years relevant biostatistics and clinical database experience
  • 3-5 years medical diagnostics trials experience preferred

Experience and Required Skills:

  • Significant experience in analysis and reporting of study results using statistical software such as R, S-Plus,  SAS or Stata
  • 3 to  5 years biostatistics/data management and/or related work experience in in vitro diagnostic medical device or pharmaceutical development
  • Experience in 510(k) and PMA trial design and execution
  • Experience with database creation and maintenance for clinical trials within the medical device or pharmaceutical industry
  • Experience with electronic data capture (EDC) applications and clinical database applications such as Oracle Clinical
  • Working knowledge of ICH guidelines, GCP, clinical research, clinical trial process and related regulatory requirements and terminology
  • Excellent organizational skills and ability to prioritize tasks
  • Detail oriented, self-motivated, ability to work independently and in a team-oriented setting
  • Ability to effectively communicate verbally and in writing with project team members
  • The candidate should have excellent computer and computation skills and leverage technology to improve efficiency and solve problems