Manufacturing Chemist II

DiaSorin•Austin, TX

33d

About The Position

Obsessed by Science. Entrepreneurial by Nature. United by Purpose. Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions. As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios. When you join Diasorin, you are not just filling a role. You are helping build what comes next. Why Join Diasorin Build What MattersTake ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide. Innovate with Agility at a Global ScaleWork in an entrepreneurial environment that enables speed, collaboration, and global impact. Grow in a People-Centered CultureThrive in a culture that values accountability, inclusion, and continuous development. Job Scope The Manufacturing Chemist I will be responsible for delivering manufacturing requirements to support production schedule and processing of purchased product and intermediate product qualification encompassing standard and custom market products including Reagent Consumables, critical Intermediates, and Internal Use Reagents. Specifically, the role is differentiated from the Manufacturing Associate positions in that it requires an established proficiency and ownership of the critical synthesis processes and ownership in improvements for the related manufacturing processes. He/she participates in manufacturing processes to support new product design transfer, stability program, process development, equipment validations, process validations, and investigations and resolution of product/process issues. Monitoring and performing maintenance and calibration of manufacturing measuring and monitoring devices. Coordinating outsource testing requirements and maintaining laboratory supplies as well as maintaining the integrity and cleanliness of work areas. The Manufacturing Chemist I will oversee rigorous adherence to safety, material handling, and disposal requirements for hazardous chemicals is required. Updating work instructions and standard operating procedures as well as delivering associated change control. Task-specific training of new Manufacturing Associates and Manufacturing Chemists. Frequent intra-department interaction as well as frequent inter-department interfaces with Quality Assurance, Quality Control, Production Planning, Purchasing, Document Control, and Reagent Design Transfer and Process Engineering.

Requirements

Bachelor's Degree Bachelors of Science degree in the field of Chemistry, Chemical Engineering, or related field required
At least 2 years of relevant experience in a Life Sciences, Chemistry, Medical Technology, or Biotechnology field.
Emphasis in organic chemistry/synthesis desired preferred

Responsibilities

Deliver manufacturing requirements and attainment of production schedule for standard and custom market products
Deliver annual planning, material readiness, schedule coordination, and manufacturing requirements for Organic Dye synthesis processes
Deliver manufacturing requirements for qualification/processing of incoming materials, production intermediates, and stability samples
Coordinate outsource testing and interface with outsource providers as technical representative
Deliver timely completion of manufacturing sections of process documentation and related WIP move and material transactions
Deliver timely completion of physical inventory counts and associated transactions; including ownership of raw materials and intermediates associated with Dye Synthesis
Document non-conformances
Participate in design transfer and integration of new products and processes
Participate in development and implementation of process improvements; identify and drive process improvements for dye synthesis processes
Write basic equipment validation plan and reports
Participate in the execution of equipment and process validations
Update work instructions and standard operating procedures as required
Perform change control as required to support change requirements including Engineering Change Orders, Document Change Control, and Deviations
Participate in investigations and resolution of findings impacting the Manufacturing Organization identified through audits, non-conformances, key performance indicator trends, corrective/preventive actions, or customer complaints escalation
Monitor maintenance and calibration schedule; perform timely maintenance and calibration of Manufacturing measuring and monitoring devices
Monitor non-inventory supplies, maintain focused supplies, and generate Purchase Orders as needed
Maintain cleanliness and integrity of manufacturing areas, storage areas, and cleanroom
Participate in applicable departmental and interdepartmental training; maintain current training to standard operating procedures per matrix, work instructions, and applicable changes affecting the Reagent Manufacturing
Participate in task-specific training of new Reagent Manufacturing Associates and Manufacturing Chemists
Assist in establishing annual CAPP objectives; fulfill individual CAPP objectives
Interface with other departments as required
Maintain personal compliance and facilitate departmental compliance with the Luminex Quality System
Adhere to safety, disposal, and gowning requirements; facilitate departmental compliance
Other duties as assigned.