Job Summary
The Assay Development Scientist III Performs a variety of tasks, including supervisory activities, associated with the development of new products and new manufacturing process-es, the investigation into and implementation of product and process changes, and the transfer of new products and processes to the manufacturing departments. Oversees and provides leadership to cross functional development team in developing new products using Design Controls. Works at strategic and tactical levels by participating in identifying resources for the department including facility, equipment, personnel, and budgetary requirements.
ResponsibilitiesKey Accountabilities
Performs activities associated with the development/launch of new products and devel-opment/implementation of new manufacturing processes Performs departmental activities according to department procedures and/or supervisory instructionsCompletes tasks within procedure- or department-defined time framesPerforms specified supervisory activities as directed by departmental managementParticipates in developing departmental procedures, quality plans/device master records, and/or work instructionsImplements special projects and validations, as neededParticipates in training and the development of employee skillsPerforms administrative functions to ensure the appropriate day to day departmental operationsParticipates in procuring facility, equipment, personnel, and budgetary resources required by the departmentParticipates in forecasting future departmental needs for equipment/capitalParticipates in departmental internal audit processEnsures department records are legible and are stored according to procedure/work-instruction-defined protocols and time framesFollows applicable laboratory OSHA regulations with respect to chemical hazards, blood-borne pathogens, safety, etc.Understands ANSI/ISO/ASQC Q9001, 21 CFR 1 – 99, 200’s, 800’s ,600’s and EN46001 standards as applied to corporate quality systemUnderstands source, composition, and characteristics of products and associated chemical and biosafety hazardsFollows applicable company procedures for the documentation of training of employeesInteracts cooperatively with coworkers, managers, and employees of other departments. Receives direction well from superiorsImplements special projects, as neededNetworking/Key relationships
Works closely with other R&D groups, Systems Engineering, Quality, Regulatory, MTS, and occasionally Marketing and Clinical teams.
QualificationsMinimum Knowledge & Experience required for the position:
Doctoral degree (PHD) or equivalent combination of education and experienceFour to ten years of related work experience.Experience in IVD development (assay focus) requiredScience or Engineering DegreeSkills & Capabilities:
Excellent written and verbal communication skills.Excellent analysis, troubleshooting, and debugging skills.Ability to perform in a fast-paced, agile environment.Ability to operate independently and exercise good judgmentUnderstanding of technical content and the ability to communicate well with subject matter expert Works well with others in a collaborative, goal-driven environmentAbility to read analyze and interpret common scientific and technical journals Ability to respond to common inquiries and complaints from customers, regulatory agencies.Ability to effectively present information to management.Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.Travel requirements:
N/A
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