Development Scientist III - Transfusion at Werfen GmbH

Norcross, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jun, 26

Salary

0.0

Posted On

08 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Assay Development, Product Development, Process Development, Design Controls, Supervisory Activities, Troubleshooting, Analysis, Debugging, Communication, Project Implementation, Validation, Quality Systems, Regulatory Compliance, Team Leadership, Resource Allocation, Budgeting

Industry

Herstellung medizinischer Geräte

Description

Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care 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 Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Responsibilities

The Assay Development Scientist III performs supervisory activities related to developing new products and manufacturing processes, investigating changes, and transferring validated processes to manufacturing departments. This role involves leading cross-functional teams using Design Controls and participating in strategic resource planning for the department.