Chiesi USA, Inc. · 20 hours ago
Intern, Manufacturing Sciences & Technology - Summer 2026
Cary, NC
Internship
Hybrid
Intern
Start in 2026 SummerChiesi USA, Inc. is an international research-focused biopharmaceutical group dedicated to promoting a healthier world. The internship role involves supporting the Global Manufacturing Division by assisting in the implementation and oversight of CGMP production and QC of products, ensuring compliance with FDA regulations and statistical process controls.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
University student currently pursuing a BS/BA, Masters, or PhD in Chemistry, Chemical Engineering, Biomedical Engineering, Statistics, Biological Sciences or equivalent scientific degree with an expected graduation date of Fall 2026 or later
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
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 including meeting facilitation, effectively setting agendas, minutes, actions and decisions. Capable of reviewing and holding themselves and others accountable to established timelines
Preferred
Biologics and Aseptic processing experience is preferred but not required
Hands on experience in laboratory setting and technical documentation of Scientific Method is preferred
Understanding of US federal regulations and processes are preferred
Company
Chiesi USA, Inc.
Chiesi USA is a pharmaceuticals company specializing in pharmaceutical research & development services.
Founded in 2014
201-500 employees
H1B Sponsorship
Chiesi USA, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$0MKey Investors
North Carolina Biotechnology Center
2020-08-04Grant· $0M
Leadership Team
Jon Zwinski
Chief Executive Officer - General Manager
Molly Rice
Senior Human Resources Business Partner / Associate Director Human Resources
Recent News
Clinical Trials Arena
2024-05-24
Company data provided by crunchbase