Intern, Manufacturing Sciences & Technology - Summer 2026

This internship supports the success of the company by assisting the Global Manufacturing Division (GMD) implementand overseeCGMP production and QC of its products. Most products sold in the USA are produced through third-party Contract Manufacturing Organizations.

This intern will ensure Chiesi's products are produced and tested under fully FDA compliant systems and processes.This role is instrumental insupporting theestablishmentand implementation of robuststatistical process controls acrossall ofChiesi's commercially manufactured products.

CommercialManufacturingProduct Support

• Manage the manufacturing activities of Chiesi's commercial portfolio, including non-sterile, biologic, and sterile products at Contract Manufacturing Organizations (CMOs) in collaboration with QA, Regulatory Affairs,and Supply Chain.
• Support the maintenance of acommercial product portfolio in compliance with technical requirements from existing and new FDA regulations,in accordance withCGMP principles.
• Use of statistical techniques andscientific rationale for monitoring CGMP processes.
• AssistTechnical Subject Matter Expertsforassigned products.
• Provide technical support for post-approval product changes in collaboration with QA and RA.
• Support andManage Risk Management efforts related to manufacturing efforts, according to FDA and ICH requirements.
• Author, and/or review and approvetechnical documentation, includingprotocols, reports, and technical documents in a precise and scientifically sound manner.
• Review andincorporatefeedback on all technical documents provided by the CMOs prior to implementation(studies, protocols, reports,risk assessments,statistical process controls, etc.).
• Provide project updates to internal and external stakeholders on a regular basis.
• Plan, manage, andmonitorstudy experiments at CMOs or contract laboratories.
• Conduct technical reviews and summaries for CMO based investigations, Change Controls, CAPAs, and Process improvements.

• University student currently pursuing aBS/BA, Masters, or PhD in Chemistry, Chemical Engineering,Biomedical Engineering,Statistics,BiologicalSciencesor equivalent scientific degreewith an expected graduation date of Fall 2026 or later.
• Effective Communicator in both verbal and writtencommunications.
• Experience with statistical software packages andknowledgeable incorrectuse ofstatistical techniques isrequired.
• Knowledgeable ofchemical, biochemical, and microbiologicalprocess equipment,analytical methodinstrumentation.
• Capable of working independently withsomesupervision, a proven self-starter, with a proactive approach to their work.
• Demonstrated capability to work collaboratively within multiple teams, organizations, andcultures;capable of exercising influence without authority when necessary.
• Experience working in ahybridenvironment andcompletingworkproduct.
• Proficiencyin reading, interpreting, and evaluating process and analytical related data.Fundamental understanding of statistics and process controls isrequired.
• Strong technical writing skills, including technical protocols, reports, investigations,risk assessments,and technical justifications.
• Ability to successfully manageand prioritize appropriatelywhenmultiple tasks and multifunctional resourcesare required.Maintainsahighattention to detail while responding to changing priorities and aggressive deadlines.
• Proficient in MS Office (Word, Excel, MS Teams, Microsoft 365), JMP, Minitab,and Adobe.
• Project management skills including meeting facilitation, effectively setting agendas, minutes,actionsand decisions.Capable of reviewing and holding themselves and others accountable toestablishedtimelines.

• Biologics and Aseptic processing experienceis preferred but notrequired.
• Handsonexperience inlaboratory settingand technical documentation of Scientific Methodis preferred.
• Understanding ofUS federal regulations and processesare preferred.

This is a hybrid rolebased inCary, NC. Interns are expected to work on-site up to 3 days per week.