Scientist

• Serve as operational lead for receiving, assessing, obtaining follow-up, processing, and reporting global adverse drug events
• Conduct peer review in the KabiSafe LSMV database and Global Complaint Management Workflow for Drug Safety Scientists and Data Specialists
• Liaise with the Global Vigilance Medical Manager/PV Physician for medical review and assessment
• Act as Subject Matter Expert for adverse drug event processing and FDA reporting
• Conduct interdepartmental training on adverse event procedures
• Lead planning, development, and maintenance of training materials as needed
• Oversee preparation of Periodic Adverse Drug Experience Reports and individual case safety reports
• Maintain knowledge of regulations, SOPs, guidelines, product labeling, regulatory safety publications, and company product data
• Lead development, implementation, and management of Safety Data Exchange Agreements and perform ADE reconciliation activities as needed
• Lead implementation and monitoring of REMS programs as needed
• Collaborate with Global Vigilance to identify and resolve case-processing compliance issues
• Interact with Quality and Regulatory Departments to resolve safety and quality issues
• Assist in creating and revising department procedures and policies
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems
• Perform additional tasks and responsibilities as required

Drug safety scientist leading adverse-event reporting for Fresenius Kabi’s healthcare products

Senior Drug Safety Scientist

Senior drug safety scientist leading adverse-event processing, FDA reporting, and compliance for Fresenius Kabi’s injectable medicines and clinical nutrition products. Collaborating with global vigilance, quality, and regulatory teams.

• Evaluate extractable and leachable study designs to meet regional requirements, including USP and ISO 10993
• Perform extractable and leachable testing in a cGMP laboratory environment
• Conduct method development, method validation, and stability testing
• Serve as a subject matter expert in mass spectrometry and extractable/leachable studies
• Operate and troubleshoot GC/MS, HR-LC/MS, and other analytical methods
• Evaluate analytical results and identify trends, exceptions, and interpretations related to chemical characterization, product requirements, and toxicological assessment
• Draft, review, and approve E&L analytical testing protocols and reports
• Perform mass spectral interpretation and unknown compound identification
• Prepare E&L studies and safety assessment summaries for regulatory dossiers
• Communicate strategic focus and project plans to team members
• Communicate project status and hurdles with managers, peers, cross-functional teammates, and non-technical audiences
• Provide technical training to other scientists and train junior scientists
• Lead E&L project activities and manage project milestones
• Write, review, and approve analytical methods, validation protocols and reports, E&L testing reports, SOPs, technical memos, investigation reports, change controls, and regulatory dossier content

Senior Scientist evaluating extractables and leachables for injectable medicines and FDA submissions

Senior Scientist, Extractable & Leachable

Senior Scientist evaluating extractables and leachables for Fresenius Kabi’s injectable medicines and FDA submissions.
Operating mass spectrometry methods, validating analyses, interpreting compounds, and preparing regulatory dossier content.

• Develop, tune, and optimize novel assays, algorithms, machine learning and statistical models to analyze next-generation sequencing (NGS) and multimodal data for oncology biomarker detection from cell-free DNA
• Develop and refine machine learning models for cell-free circulating tumor DNA fraction estimation and longitudinal treatment response monitoring
• Improve molecular barcoding filtering strategies to distinguish low-frequency oncology biomarkers from sequencing artifacts
• Design and integrate machine learning classifiers and filtering logic to differentiate Clonal Hematopoiesis variants from tumor-derived variants
• Design and execute experiments evaluating assay analytical performance
• Support regulatory documentation for CAP/CLIA, New York State, FDA, and MolDx submissions
• Collaborate with wet-lab assay development scientists, medical directors, clinical scientists, biostatisticians, software engineers, and product managers
• Translate research into clinically actionable insights and production-scale pipelines

Bioinformatics Scientist developing liquid biopsy assays and AI for Tempus precision oncology

Bioinformatics Scientist

Bioinformatics Scientist developing liquid biopsy assays and AI models for Tempus, a precision oncology company. Optimizing biomarker detection, tumor fraction estimation, and clinical validation pipelines.

• This position is responsible for building and executing a pipeline of research and development activities specifically relating to materials science
• Development/implementation of new resins/barriers/additives/processes
• Increasing usage of Post Consumer Recycled resins
• Work extensively with both internal & external partners to lead development of next generation materials science solutions that enable more sustainable products in the market place
• Lead research & decision making relative to new resin solutions and alternatives
• Drives ongoing innovation and technology scouting activities in sustainability, particularly materials arena
• Internal expert regarding PCR usage and approaches/methods for increasing amount of PCR in RPSNAB products
• Maintain timelines and budgets as it relates to material development programs aligned with overall business objectives
• Collaborative work style exhibiting willingness to learn as well as teach/coach others
• Strong program management skills and experience with ability to lead high priority, cross-functional development program including indirect leadership of cross-functional project teams
• Prescribe the use of appropriate project management & engineering tools for development & implementation of resin/barrier solutions
• Provide technical guidance to engineering, manufacturing and other internal/external customers as required
• Supports BU’s to create business case for resin/barrier solutions including targeted performance specifications, costing, & overall value proposition
• Establish inspection protocol and validate new product & materials specifications
• Combines lateral/creative thinking with scientific knowledge to achieve results
• Knows the business well enough to understand overall market needs and to predict future needs
• Ability to work autonomously and adds value in all phases of a project and applies analytical skills
• Seek feedback and correct own performance
• Oversees resin trials and/or participate in material selection activities
• Specifies & approves lab work requests including sign-off on resin/process configurations and oversight of the qualification of new resins/materials where applicable
• Strong written and oral communication and interpersonal skills
• Requires tact and effectiveness in dealing with a wide variety of stakeholders in everyday working relationships & executive reporting/communication.
• Maintain and enforce all company safety, environmental, and department of health requirements.

Senior Scientist developing sustainable materials science solutions at Amcor

Senior Scientist

Senior Scientist developing solutions for sustainable packaging at Amcor. Leading innovation in materials science and collaborating with teams to implement new technologies.

• Provide expert support during pre- and post-sales activities, including scientific, technical, and application assistance.
• Deliver hands-on training by scheduling and managing demos, instrument installations, and customer onboarding sessions.
• Simplify complexity by presenting technical material in an engaging and accessible way, while professionally addressing questions or objections.
• Collaborate with the sales team to identify customer needs and demonstrate tailored product solutions.
• Assist customers with assay development, data analysis, and reporting to support their equipment purchase decisions.
• Monitor industry trends by maintaining knowledge of competitive products and emerging technologies.
• Advocate for customers by acting as the voice of the customer to internal teams and sharing valuable feedback about product performance and market needs.
• Build relationships by resolving inquiries, investigating complaints, and ensuring customer satisfaction.
• Contribute to market growth by supporting collaborations, preparing technical materials for seminars, and representing the company at scientific events and trade shows.

Field Application Scientist supporting biotech and pharmaceutical industries with expert instruments.

Field Applications Scientist

Field Application Scientist supporting biotech and pharmaceutical industries with Axion’s live cell analysis instruments. Engaging with customers during pre-sales and post-sales processes and providing expert technical assistance.

• Lead internal upstream process development efforts at the Sumitomo Biorational Company Biorational Research Center by conducting fermentation experiments in laboratory- and pilot-scale bioreactors.
• Evaluate the performance of microbial strain candidates by analysis and interpretation of fermentation data.
• Work with a team of fermentation scientists, downstream process engineers, formulations scientists, microbial engineers and analytical chemists to develop sustainable biorational solutions within the expanding field of BioAgriculture.
• Design and implement upstream processes to optimize strain performance of bacterial and fungal microorganisms to produce microbial products, metabolites and proteins.
• Mentor junior team members by training safe and proper use of fermentation and analytical equipment required to execute process development and improvement experiments.
• Provide guidance to research associates and support their professional development.
• Take primary responsibility for the operation and troubleshooting of pilot scale fermentation equipment.
• Design scale up and scale down experiments to execute seamless technology transfer between Research and Manufacturing operations.
• Build strong relationships with supporting research departments and deliver fermentations on time or ahead of schedule to biology, downstream processing, formulations, and product development teams.
• Travel to manufacturing site to launch new fermentation processes and troubleshoot current commercial processes.
• Maintain and further develop collaborative relationship with the pilot and production fermentation team at the manufacturing site.
• Execute sophisticated process development experiments utilizing statistical tools to ensure process robustness.
• Work alongside data scientists, IT, and engineering to build and maintain a digital system to organize and archive run data and electronic batch records.
• Maintain and update laboratory data and documents including electronic lab notebook and SOPs.
• Conduct all work in strict compliance with all applicable safety requirements, containment requirements, standards operating procedures and/or guidelines while maintaining a clean and orderly workspace.
• Work both independently and with interdisciplinary research teams while maintaining a positive and collaborative environment.

Lead upstream fermentation experiments for biorational solutions at Sumitomo Biorational Company

Senior Fermentation Scientist

Lead upstream fermentation experiments for biorational solutions at Sumitomo Biorational Company. Collaborate with interdisciplinary teams to develop and implement sustainable agricultural innovations.

• Assist in the product development process across a diverse set of categories
• Utilize our ingredient portfolio to solve for customer interests and challenges
• Document processes, formulas, ingredients, and results related to production tests
• Responsible for entering raw materials into PLM database system
• Perform all work in accordance with Ajinomoto GMP, Allergen, and Quality Programs
• Mentor and onboard more junior-level employees
• Apply technical expertise in food science to ideate and develop product/concepts/prototypes
• Conduct sensory evaluations of new products in collaboration with the sensory department
• Participate on sensory panels helping other technical personnel

Food Scientist developing soups, stocks, and broths at Ajinomoto Health & Nutrition

Food Scientist – Soup, Stock & Broth Innovation

Food Scientist developing soups, stocks, and broths at Ajinomoto Health & Nutrition. Collaborating on product development using ingredient portfolios to meet customer demands.

• Assist in the product development process across a diverse set of categories
• Utilize our ingredient portfolio to solve for customer interests and challenges
• Document processes, formulas, ingredients, and results related to production tests, samples and product evaluations
• Responsible for entering raw materials into PLM database system
• Perform all work in accordance with Ajinomoto GMP, Allergen, and Quality Programs
• Mentor and onboard more junior-level employees
• Apply technical expertise in food science to ideate and develop product/concepts/prototypes
• Conduct sensory evaluations of new products in collaboration with the sensory department
• Participate on sensory panels helping other technical personnel with their work
• Conduct and participate in shelf-life studies for Ajinomoto products
• Write standard operating protocols for analytical methods and use of technical equipment
• Manage and advance short-term, 2-4 week projects
• Perform other duties as assigned

Food Scientist assisting in product development at Ajinomoto Health & Nutrition

Food Scientist

Food Scientist assisting in product development utilizing ingredient portfolio to solve customer challenges. Collaborating on sensory evaluations and documenting processes related to food product testing.

• Accurately classify somatic and germline variants
• Utilize in-house software tools to analyze clinical molecular data
• Read and interpret scientific literature
• Summarize genetic test results for clinical reports
• Perform quality control for molecular reports

Variant Scientist working with Clinical Teams on patient molecular reports

Variant Scientist

Variant Scientist working with Clinical Teams on patient molecular reports for clinical utility. Involved in classifying genetic variants and summarizing test results.

Scientist jobs in Illinois

See all jobs on JobTailor