Job Description:
The QA Lab Coordinator will support the QA Supervisor in the SCMM Clinical Laboratory operations for the required Laboratory Standard Operating Procedures (SOPs), the Laboratory Information Management System (LIMS), and all required licensing and certification for the Laboratory and its staff.
The ideal candidate will assist in process improvement and process design to rigorously apply Quality methods to comply with federal, local and company regulatory standards.
Responsibilities:
- Provide support with the Clinical Laboratory staff and ensure that Standard Operating Procedures (SOPs) are properly documented, approved, and updated according to requirements
- Ensure that all required CLIA, CAP, state, and other regulatory body licenses, certifications, and notifications are submitted, obtained, and maintained
- Work closely with QA Supervisor to ensure all aspects of the Quality Assurance process are completed within the accepted timeframe and according to division standards
- Maintain appropriate and secure files of the Clinical Laboratory documents and SOPs
- Assist with document control database updates, maintain manual documents for approval, promote active QA manual documents, and format QA Manual documents per requirements
- Coordinate ongoing maintenance of technical policies/procedures retained under document control
- Assist with maintaining equipment and calibrations on a timely basis
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Job Description:
The Regional Business Director will be responsible for the oversight of the field sales team in their geographical regions of the country. The ideal candidate will direct sales efforts to achieve molecular diagnostics sales and corporate goals which include developing and executing sales plans for the portfolio of products. Additionally, this position will develop and maintain a strong, consistent corporate image as well as drive sales through strategic and tactical marketing plans.
Responsibilities:
- Develop and execute regional commercial strategies to drive product adoption and growth, including strategic and tactical regional marketing plans and sales strategies
- Achieve annual sales plan goal in support of organizational strategy and objectives
- Direct implementation and execution of sales policies and practices
- Lead, build, expand, train, and motivate the Regional Team
- Partner with Sales Operations to establishing sales territories, quotas, and goals
- Develop relationships with customers, community, academic medical centers and KOLs
- Partner with marketing to develop key messaging and tactical programs to drive growth
- Lead future product launches
- Understand and enforce all applicable corporate and regulatory policies and procedures
- Recommend sales strategies based on market research and competitor analysis
- Partner with IT to develop potential of CRM Salesforce.com
- Report on key issues as appropriate to VP Sales, and Senior Leadership Team
- Provide leadership in developing consultative selling skills and clinical of knowledge of sales team
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Job Description:
Support Sequenom Governance, Risk and Compliance Assurance requirements related to Regulations and Standards such as SOX, HIPAA, PCI-DSS, CobIT, NIST and ITIL.
Responsibilities:
- Demonstrate advanced understanding of Business processes, Internal controls, Risk Management and related IT Governance, Risk and Compliance standards.
- Research, evaluate, develop, implement and administer IT Internal Audit requirements for applicable regulations and Standards.
- Conduct annual Information Systems Internal Controls risk analysis; maintain Risk Control Matrices, and Control Narratives.
- Conduct Internal and External IT Compliance Audits and Assessments; provide analysis, recommendations as required.
- Manage interactions with External auditors, Consultants and Regulators regarding the requirements and performance of all audits and examination engagements.
- Collaborate in the design, development and presentation of IT Governance, Risk and Compliance related training.
- Periodically prepare and provide reports on Information Technology Governance, Risk and Compliance efforts.
- Lead planning and execution of projects in areas of: Risk Management, Privacy Compliance, IT Security Audit, and IT Risk Management.
- Should have aspirations to have a broad career in Governance, Risk and Compliance Assurance
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Job Description:
Sequenom has a Scientist position available in the R&D, Diagnostic Development department. This Scientist will be responsible for the creation of novel approaches as well as the evaluation and development of biochemistries and technologies related to Laboratory Developed Tests and potential In vitro Diagnostic assays. The ideal candidate will apply extensive knowledge of molecular biology, instrumentation, biochemistry, and bioinformatics in the development and optimization of nucleic acid detection assays performed via next-generation sequencing and mass spectrometry.
Responsibilities:
- Utilize molecular biology techniques in the manipulation of nucleic acids for the development of novel diagnostic assays
- Evaluate, develop, optimize, and automate biochemistries which may be useful in existing or future versions of Laboratory Developed Tests
- Evaluate new technologies and platforms for use in a high throughput diagnostic environment
- Create and optimize liquid handling protocols to streamline and standardize assay performance
- Design appropriate model systems for proof-of-concept studies
- Design experiments, execute protocols, and analyze data for qualitative and quantitative review
- Assist in the organization, cross-functional coordination, and execution of validation studies
- Perform data analysis with graphical representations of findings using appropriate software (Excel, JMP, R)
- Document all work in the form of laboratory notebook, study reports, and summary reports
- Present data clearly and concisely at departmental meetings and conferences
- Publish scientifically relevant data in peer reviewed journals
- Participate in the development of patent applications, if applicable
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Job Description:
Provides operational readiness for the SAP system landscape as it evolves through development, test, QA and production. Performs system installation, user administration, system access management, performance monitoring, system upgrades, and applies system patches (OSS notes, support packages, add-ons).
Responsibilities:
- Installs, configures and maintains the basis components of SAP systems and external interfaces
- Assists in the planning, designing and architecting of the SAP landscape across a variety of platforms and databases
- Installs support packs, conducts upgrades, performs system refreshes, administers databases, and conducts failover tests of production systems
- Diagnoses and resolves problems; monitors and tunes performance
- Reports progress to goals, identifies key risks and mitigation strategies, and provides direct support for other process teams
- Works extensively with others within the SAP group, the IT Department and with others outside the IT Department
- Provides SAP support for acquisitions and related integrations
- Assists in creating and maintaining new and existing SOX controls, participate in internal and external auditing procedures
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Job Description:
The Technical Writer will be responsible for the technical, clinical and regulatory writing of laboratory and quality system documentation. This position will be responsible for translating procedures and data into laboratory and regulatory compliant materials. The Technical Writer will communicate with quality specialists, scientists and laboratory personnel. The ideal candidate will be experienced in gathering information and detail oriented in incorporating edits from various stakeholders into a final, publishable form.
Responsibilities:
- Develop scientific/technical/clinical/regulatory content for delivery in a variety of formats
- Research, draft or revise content, route content for input, and finalize content for delivery to internal customers
- Simultaneously manage multiple projects with multiple deliverables and deliver quality product under deadlines
- Proactively identify process improvements
- Identify and communicate risks in advance
- Adhere to relevant processes, style guides, templates, and brand guidelines or create them if they are not existent
- Develop content that:
- Meets the needs of the target audience
- Is accurate, clear, and concise
- Follows relevant best practices
- Applies best practices in technical/scientific/regulatory writing to suggest content, organize content, and, if appropriate, plan page layouts
- Manages projects via relevant tracking method
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Job Description:
The National Account Director, Managed Care is responsible for the development and implementation of selling strategies to gain access to and successfully manage GPO (Group Purchasing Organization), Private Payers, IDN (Integrated Delivery Network) and State Medicaid accounts. Reporting to the Senior Director, National Accounts and Payor Strategies, the National Account Director works medical affairs, sales, marketing, laboratory operations and other applicable company personnel to secure contracts for Sequenom tests to maximize company sales.
Responsibilities:
- Develop and manage key national assigned payor accounts.
- Responsible for developing strong account relationships at an executive level for the purpose of growing sales of Sequenom’s prenatal tests.
- Develop and coordinate sales presentations and manages account development.
- Responsible for gaining new contracts and then driving all associated activity to implement the strategy related to those contracts.
- Have primary responsibility for sales in assigned accounts. Negotiates pricing and contract terms with customers.
- Acts upon final approval from the Senior Director, National Accounts and Payor Strategies. Provides the primary executive interface between the company and payer customers. Monitors changes in all assigned account sales and service levels.
- Develop business plans for each account assigned; monitors and reports progress monthly and develops and implements tactics to exceed sales and company goals. Monitors business progress and advises Sequenom management of results. Takes corrective action when needed to ensure that goals are met.
- Coordinate with internal departments to develop and implement timely contract launches and renewals. Coordinate and presents Sequenom value proposition and customer solutions in a selling situation. This includes product development activities, packaging, promotions, pricing, billing, customer service and contracts.
- Facilitate the management of key business relationships and negotiates potential business opportunities for the company which are consistent with its long-term national account strategy.
- Perform other contract or sales related duties as the need arises.
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Job Description:
The Sr.Account Manager will be responsible for managing the national network of phlebotomy providers to support the needs of the clients, patients, and SCMM (Sequenom Center for Molecular Medicine) commercial organization. The ideal candidate will develop a strong relationship with the field organization and client base to ensure the seamless collection of patient specimens in a convenient and professional environment, while establishing a highly positive working relationship on behalf of SCMM with our phlebotomy providers.
Responsibilities:
- Lead day-to-day management of Sequenom Center for Molecular Medicine’s national network of phlebotomy providers
- Proactively lead the development and acquisition of new phlebotomy accounts
- Manage phlebotomy site setup, training, and quality performance standards
- Develop and maintain key performance indicators for phlebotomy network including access coverage, supply inventory, and impact analysis
- Maintain Field Sales’ awareness of the contracting status of new accounts
- Manage phlebotomy supply inventory and development of an auto -ship system
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Job Description:
Due to our rapid growth, we are looking to hire Clinical Laboratory Supervisors who will be responsible for monitoring the production of medical diagnostic testing in the CLIA lab performed by assigned Clinical Lab Scientists. The supervisor will work closely with internal and external contacts including suppliers, physicians and other healthcare providers regarding clinical laboratory testing, operations and development of new tests. They manage routine and complex molecular biology procedures including analyzing and interpreting results and initiating, developing and implementing assays. They are responsible for supervising assigned Clinical Lab Scientists and Lab Associates.
Responsibilities:
- Manage the daily operation of assigned laboratory group to ensure that specimens are properly shipped and received, tests are performed accurately and efficiently, and results are reported in a timely manner.
- Perform pre-analytical, analytical and post analytical test process and evaluate results produced relative to the diagnostic assessment
- Evaluate data for accuracy and verify any questionable finding with proper documentation, thorough investigation, and appropriate follow-through
- Assist with designing processes and procedures to ensure efficient turn-around time and accuracy of results.
- Prepare and manage laboratory budget
- Coach and mentor staff on technical expertise and assists in evaluation of employee competencies.
- Engage in continuous process and service improvement. Make and implement recommendations to improve operational efficiency and implement new services for areas of responsibility.
- Requires strict adherence to quality control guidelines to ensure integrity of laboratory specimens and accuracy of results
- Ensure all work is in accordance with state and Federal regulations, organizational policy, and accreditation/compliance requirements
- Assist in maintaining CAP, CA State, FDA, and other accreditation and regulatory agency standards and regulations.
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