Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
Internship Program Overview
Our 10-week summer internship program gives students hands-on experience and the opportunity to make a meaningful impact while learning about our organization. Interns will connect with leaders, participate in development sessions like self-assessments and business overviews, and take part in networking and community initiatives. The program concludes with a final presentation to leaders and peers, where interns showcase their work, share ideas, and receive valuable feedback.
Who we are looking for
This is what you will do
This internship supports the success of the company by assisting the Global Manufacturing Division (GMD) implement and oversee CGMP 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 in supporting the establishment and implementation of robust statistical process controls across all of Chiesi's commercially manufactured products.
You'll be responsible for:
Commercial Manufacturing Product 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 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.
You will need to have
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.
We would prefer for you to have
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.
Location
This is a hybrid role based in Cary, NC. Interns are expected to work on-site up to 3 days per week.
What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
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, marital status, veteran status, 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.
