What are the responsibilities and job description for the Intern, Manufacturing Sciences & Technology - Summer 2025 position at Chiesi Group?
Who we are looking for
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
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.
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
