Technical Services Specialist - Biomatrica Inc.

Summary of Major Responsibilities:

Exact Sciences is seeking a Technical Services Specialist to join the Technical Service and Support Team.  The successful candidate will help create training materials, processes, and systems that will ensure efficient introduction and successful ongoing use of Exact Sciences in vitro diagnostic (IVD) and Lab Developed (LDT) products by customer laboratories worldwide.  He or she will provide internal and external (customer) training, technical support, and will participate in monitoring of performance and customer experience with these IVD and LDT products.  These activities can be conducted both at Exact facilities, as well as in customer facilities.  The successful candidate will respond to customer inquiries and complaints regarding product performance, troubleshooting customer issues, and ensuring that all customer concerns are resolved to the customer’s satisfaction.  The Technical Services Specialist will collaborate closely with Operations, R&D, Sales, Quality Assurance, Customer Service, Product Lifecycle Management, and other departments to achieve these objectives.

 

This position is ideally located in San Diego, CA.

Essential Duties and Responsibilities:

• Develop and deliver training materials (e.g., manuals, instructions, technical bulletins), as needed, and implement training and service programs to support the launch of Exact Sciences’ IVD and LDT products; which may include assays, reagents, software, and instruments.
• Provide training to customers and internal personnel in Field Applications Support, Customer Service, Sales, and other functions, as needed.
• Develop and deliver online customer training and support tools (i.e., webinars) appropriate for global customers.
• Follow escalation processes, internally and externally, with commercial field technical support staff to rapidly resolve global customer and IVD and LDT product issues.
• Ensure that technical issues, customer complaints, and all issues of customer relations and customer service are followed up on appropriately and in a manner compliant with IVD and LDT regulatory requirements and corporate policies.
• Collaborate effectively with other functional teams across the company to successfully conduct technical troubleshooting efforts with commercial products.
• Clearly and accurately summarize and documents troubleshooting activities or technical summary.
• Collaborate effectively on cross-functional teams, including R&D, Operations, Quality Assurance, IT, Product Lifecycle Management, Sales, etc., and other functions, as required, to help develop and deliver training and ongoing support to our customers and employees.
• Manage, track, and escalate, as appropriate, customer requests for support, questions, complaints, and feedback, while continuously improving processes and systems for these customer interactions.
• Collaborate with new product development teams to provide support requirements to ensure that new products are designed for supportability and serviceability.
• Contribute to the development and delivery of a customer training certification program.
• Contribute to the development of written procedures and training materials for installation and qualification of IVD instrumentation and software by Field Applications Specialists.
• Exceptional written and verbal communication, collaboration, and teaching skills, at all levels of the company and with customers.
• Ability to collect, organize, and use customer feedback to drive ongoing improvement in products and services.
• Ability to train and support clinical laboratories (hospital or reference labs).
• Superior technical support skills; including the ability to be empathetic, accurate, resourceful, and conscientious.
• Excellent judgment to prioritize customer issues based on urgency and severity.
• Superior interpersonal skills; ability to work effectively with a diverse group of people at various levels within an organization, both within Exact or at remote locations outside the company.
• Exceptional time management, organizational, and adaptability skills to successfully work in a fast-paced work environment with changing priorities.
• Ability to effectively communicate complex technical information in product manuals or related documentation, individual or small group discussions, and in technical presentations to customers and/or Exact personnel.
• Ability to work on multidisciplinary project teams for new product development and product launch.
• Ability to rapidly assimilate new information, define problems, collect data, establish facts, and draw valid conclusions to resolve complex problems.
• Entrepreneurial mindset; strong desire to work in a fast-paced, highly interdisciplinary environment with rapidly changing priorities.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to lift up to 25 pounds on an occasional basis.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to respond effectively to sensitive inquiries or complaints from customers, regulatory agencies, or members of the scientific community.
• Considerable amount of time maybe spent using various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes.
• May perform repetitious actions using lab tools.
• Some time spent using near vision to view samples at close range.
• Use of various chemicals may be used to perform duties.
• Use of computer and some time may be spent concentrating, reading, or analyzing data, or applying scientific rules.
• May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability to travel 30% of working time away from work location, may include overnight/weekend travel.

Qualifications:

Minimum Qualifications

• Bachelor’s Degree in a Scientific or Engineering field.
• 5+ years of experience providing customer technical/applications support for in vitro diagnostic (IVD) products and/or laboratory developed test (LDT) products.
• Strong working knowledge of NGS; including lab work, data analysis, and troubleshooting.
• Strong working knowledge of molecular diagnostics methodologies and reagents, and ability to use instrumentation and software (e.g., for nucleic acid extraction, quantitative RT-PCR, gene expression and mutation analysis methods, and related techniques).
• Demonstrated ability of problem-solving skills related to issues on assays, instrumentation, and software.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Bachelor’s degree in a Molecular Biology, Science, or Engineering field.
• 2+ years of lab experience using Histology techniques; including sectioning, H&E staining, macro dissecting, and process troubleshooting.
• 1+ years of experience in a high throughput laboratory production environment using LIMS, ERP, Data Management systems; or equivalent Exact specific experience.
• Demonstrated practical working knowledge of global IVD regulations and quality standards; including FDA QSR, ISO 13485, IVDD, IVDR, and others relevant to molecular diagnostics.
• Strong understanding of the Quality System Regulations and Service requirements defined therein.

EEO Disclosure:

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.