Manufacturing Chemist II

About the role

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.

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

Qualifications

Bachelor's Degree: Bachelors of Science degree in the field of Chemistry, Chemical Engineering, or related field required.

2+ Years: At least 2 years of relevant experience in a Life Sciences, Chemistry, Medical Technology, or Biotechnology field. Emphasis in organic chemistry/synthesis desired preferred.

Benefits

Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance. Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.