Intern, Manufacturing Sciences & Technology - Summer 2025

Purpose

This position contributes to the company success by aiding the Global Manufacturing Division (GMD) implement and oversee CGMP production and QC of its products. Virtually all products sold in the USA are produced through 3rd party Contract Manufacturing Organizations. This position has the technical responsibility to ensure Chiesi’s products are produced and tested under fully FDA compliant systems and processes.  This role is instrumental in supporting the establishment and implementation of robust statistical process controls across all of Chiesi’s commercially manufactured products.

Main Responsibilities

• 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 a commercial product portfolio in compliance with technical requirements from existing and new FDA regulations, in accordance with CGMP principles.
• Use of statistical techniques and scientific rationale for monitoring CGMP processes.
• Assist Technical Subject Matter Experts for assigned products.
• Provide technical support for post-approval product changes in collaboration with QA and RA.
• Support and Manage Risk Management efforts related to manufacturing efforts, according to FDA and ICH requirements. 
• Author, and/or review and approve technical documentation, including protocols, reports, and technical documents in a precise and scientifically sound manner.
• Review and incorporate feedback 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, and monitor study experiments at CMOs or contract laboratories.
• Conduct technical reviews and summaries for CMO based investigations, Change Controls, CAPAs, and Process improvements
   

Experience Required

• Effective Communicator in both verbal and written communications.
• Experience with statistical software packages and knowledgeable in correct use of statistical techniques is required.
• Knowledgeable of chemical, biochemical, and microbiological process equipment, analytical method instrumentation.
• Capable of working independently with some supervision, a proven self-starter, with a proactive approach to their work.
• Demonstrated capability to work collaboratively within multiple teams, organizations, and cultures; capable of exercising influence without authority when necessary.
• Experience working in a hybrid environment and completing work product.
• Proficiency in reading, interpreting, and evaluating process and analytical related data. Fundamental understanding of statistics and process controls is required.
• Strong technical writing skills, including technical protocols, reports, investigations, risk assessments, and technical justifications.
• Understanding of US federal regulations and processes are preferred.
• Ability to successfully manage and prioritize appropriately when multiple tasks and multifunctional resources are required.  Maintains a high attention 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 are desirable including meeting facilitation, effectively setting agendas, minutes, actions and decisions.  Capable of reviewing and holding themselves and others accountable to established timelines.
   

Education

University student in pursuit of BS/BA, Masters, or PhD in Chemistry, Chemical Engineering, Biomedical Engineering, Statistics, Biological Sciences or equivalent scientific degree minimum.  Biologics and Aseptic processing experience is preferred but not required.