Development Scientist III Transfusion and Transplant

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. Assay Development Scientist III employees are expected to have more assay/product development related experience more technical knowledge or more scientific knowledge/background than Assay Development Scientist employees. May Supervise and manage 1-3 employees at the Development Scientist I and Development Scientist II levels.

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 200s 800s 600s 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.

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