What are the responsibilities and job description for the Intern, Manufacturing Sciences & Technology - Summer 2025 position at Chiesi USA, Inc.?
About Us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
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.
What We Offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."
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
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.
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
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.
What We Offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."
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
- 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.
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.
