PROCESS CHEMIST- US
Summary: The Chemistry Reagent Design Transfer/ Process Chemist is responsible for representing Reagent Operations in design teams for new and changed product design and development, design transfer, and market phases. The position facilitates in defining project tasks, establishing timelines, and fulfilling responsibilities for product design transfer and related process engineering. The Chemistry Reagent Design Transfer/ Process Engineer II collaborates on the development of oligonucleotide synthesis for development, analytical methods to support oligonucleotide, nucleotide and phosphoramidite production requirements. new chemistries, and/or probe-based technologies and assumes full ownership at Production release of material specifications, manufacturing processes, test methods, analysis tools, work instructions, stability studies, and related acceptance criteria for new or changed product. This requires knowledge in areas of synthesis processes, purification technology and processes, Mass Spec and HPLC analytical testing. The position entails frequent intra-department interaction as well as frequent inter-department interfaces with Reagent Quality Control, Reagent Manufacturing, Quality Assurance, Chemistry R&D, Supply Chain, Cost Accounting, Project Management, Facilities, and Document Control.
Key Responsibilities and Duties
• Represent Reagent Manufacturing Operation in design teams; fulfill design transfer responsibilities for new and changed product development, validation, and market release phases.
• Lead and assist in sustaining engineering projects for improvement of manufacturing processes, cleaning processes, stability methods, test methods, product specifications, process/test equipment/fixtures, analysis tools, and Enterprise Resource Planning.
• Lead and assist in design input and implementation oversight of infrastructure improvement projects.
• Identify opportunities for process innovations, improvement, and cost reductions.
• Participate and drive development and implementation of process automation strategies and solutions.
• Assume full ownership of sustaining support for on-market processes
• Participate in product feasibility collaborations with R&D, as needed.
• Lead and assist in engineering change control and document change control activities; participate in change control reviews.
• Collaborate with R&D on the development of material specifications, manufacturing processes, test methods, analysis tools, work instructions and related acceptance criteria for new or changed product Prototype release.
• Assume full design transfer ownership for Production and Market release of material specifications, manufacturing processes, test methods, analysis tools, work instructions and related acceptance criteria for new or changed product.
• Lead and drive design inputs and implementation oversight of infrastructure improvement projects.
• Establish and maintain standard architecture of BOMs and Routings related to new or existing Reagent Operation processes in Enterprise Resource Planning
• Interface with Cost Accounting for new or existing product COGs roll-up
• Perform cost/benefit analysis for product/process improvement projects
• Equipment Qualification Test Plans and summary reports
• Collaborate with R&D on OQ process validation planning and execution.
• Assume full ownership of PQ process validation planning, execution, and reporting; collaborate with R&D as required.
• Assume full ownership of test method and analysis tool validation planning, execution, and reporting; collaborate with R&D as required.
• Assume full ownership of equipment and test fixture validation planning, execution, and reporting; collaborate with R&D as required.
• Ensure effective training of Manufacturing and Quality Control personnel for transfer of new processes.
• Responsible for knowledge transfer of science, technology, and application context behind new product designs being transferred into Reagent Operations.
• Lead and assist the investigation and resolution of findings impacting the Reagent Operations organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation.
• Interface with other departments as required.
• Ensure personal compliance and influence sectional compliance with the Quality System and other regulations.
• Ensure personal safety compliance and influence sectional safety compliance.
Education and Experience
• Advanced degree in Chemistry, Biochemistry, Organic Chemistry or Chemical Engineering or related field or Bachelor’s degree with demonstrated directly related industrial experience.
• Knowledge of optimization of synthesis and purification methodologies for key molecules of interest preferred.
Training, Skills, Certifications and Licenses
• Manufacturing experience in a FDA and/or USDA regulated industry and/or ISO certified organization desired
• Working knowledge of ISO 13485:2003 and FDA Quality System requirements
• Familiar with systems for Enterprise Resource Planning, and Product Lifecycle Management, including applied knowledge of Engineering Change Control
• Applied knowledge of Process Validations as required by FDA Quality System guidelines
• Proficiency in routine characterization by NMR, HPLC, LC/MS and UPLC/MS
• Data analysis and technical writing aptitude.
• Excellent oral and written communication skills.
• Proficient in Microsoft Word, Excel, PowerPoint and Statistical Analysis programs.
• Highly organized with proven time management and prioritization skills
• Ability to work independently and with minimal supervision
• Ability to handle the pressure of meeting tight deadlines
• Work location on site at Luminex Office
• Travel may be required between Luminex sites and/or to suppliers etc.
• Work is typically performed in a production facility or office environment.
• Work in manufacturing setting including BioSafety Level 2 areas; work may be performed in fume hood, clean hood, biosafety cabinet, and/or ISO Class 7 cleanroom with specialized gowning and safety requirements.
• Possible exposure to mechanical, biological, and chemical hazards, extensive noise, and/or working with lasers.
• Frequent use of personal computer, and office equipment.
• Frequent use of data and word processing programs.
• Frequent standing, walking, sitting, listening, writing, typing, and talking.
• Frequent work under deadlines, as a team member, and in direct contact with others.
• Work situations include dealing with people; working alone; making judgments and decisions; and directing, controlling or planning the activity of others
- Job Family US
- Pay Type Salary
- Employment Indicator Regular
- Northbrook, IL 60062, USA