Development Scientist III - Transfusion and Transplant

Werfen•Norcross, GA

42d

About The Position

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. 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. 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.

Requirements

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
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.

Responsibilities

Performs activities associated with the development/launch of new products and development/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