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Overview

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.

Responsibilities

Key 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 instructions
• Completes tasks within procedure- or department-defined time frames
• Performs specified supervisory activities as directed by departmental management
• Participates in developing departmental procedures, quality plans/device master records, and/or work instructions
• Implements special projects and validations, as needed
• Participates in training and the development of employee skills
• Performs administrative functions to ensure the appropriate day to day departmental operations
• Participates in procuring facility, equipment, personnel, and budgetary resources required by the department
• Participates in forecasting future departmental needs for equipment/capital
• Participates in departmental internal audit process
• Ensures department records are legible and are stored according to procedure/work-instruction-defined protocols and time frames
• Follows 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 system
• Understands source, composition, and characteristics of products and associated chemical and biosafety hazards
• Follows applicable company procedures for the documentation of training of employees
• Interacts cooperatively with coworkers, managers, and employees of other departments. Receives direction well from superiors
• Implements special projects, as needed

Networking/Key relationships

Works closely with other R&D groups, Systems Engineering, Quality, Regulatory, MTS, and occasionally Marketing and Clinical teams.

Qualifications

Minimum Knowledge & Experience required for the position:

• Doctoral degree (PHD) or equivalent combination of education and experience
• Four to ten years of related work experience.
• Experience in IVD development (assay focus) required
• Science or Engineering Degree

Skills & 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 judgment
• Understanding of technical content and the ability to communicate well with subject matter expert
• Works well with others in a collaborative, goal-driven environment
• Ability 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