Act as a specialist for the local laboratory quality and technical systems including assay quality control, proficiency testing review, assay validations, instrument qualification and/or the scientific database, collaborating with Global Lab Harmonization, Assay Development Laboratory, Scientific Review, Data Management, Quality Assurance, Information Technology teams and Vendors as necessary in the execution and fulfillment of duties.
This job description reflects the major responsibilities globally and is not intended to reflect all possible duties and responsibilities for each employee in this job title. Management has the right to assign all or a portion of the duties and responsibilities of this job based upon business needs.
Complete all necessary training to become proficient on assays across multiple functional areas and be prepared to provide support for those assays as needed. Further maintain proficiencies and accreditation for these assays as needed. Demonstrate an ability to work independently to effectively manage multiple projects and/or task as well effectively communicate with operations supervisors and other lab personnel regarding status updates.
Provide input on technical inquiries and assist with producing technical documentation for laboratory assays. This includes providing data and/or information needed by other service area including but not limited to R&D, Quality, Information Technology, and Finance.
Demonstrate advance domain knowledge across multiple laboratory assays. Be able to properly demonstrate this knowledge by leading training of other lab personnel and identifying ways to improve throughput.
Actively engage in communication with junior and senior employees across multiple departments to identify areas to improve efficiencies and workflows in laboratory operations.
Develop new standard operating protocols as well as strategically troubleshoot existing protocols. This includes working with R&D, vendors and their technical support staff to troubleshoot new and existing technologies.
Assist with the R&D team to develop and implement method validation plans for new platforms. Subsequently, assisting with the transition of these platforms into the operations lab and ensuring method validation and implementation SOPs are correctly applied. This includes working across multiple teams to ensure relevant information is transferred, overseeing training of other lab personnel, finalizing SOPs and identifying areas for further improvement prior to the release of the platform in the lab.
Provide technical information or presentations to other departments with operations and communicate on a technical level with personnel across multiple departments, sales force, clients and vendors. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Knowledge of functional genomics platforms including Next Generation Sequencing technologies.
Laboratory automation experience strongly preferred.
Knowledge of clinical laboratory regulations, GxP and /or ICH guidelines.
Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures.
Proficiency in PC applications such as word processing, spreadsheets, database management.
Excellent attention to detail, organizational skills, verbal and written communication skills.
Ability to work independently as well as in a team environment.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in life sciences or other relevant field and 5 years relevant laboratory experience; or equivalent combination of education, training and experience.
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