CMC Senior Specialist - Mendrisio site (Ticino)
Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.
We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.
Position Summary:
The CMC Senior Specialist will be part of the Research and Development team and will be responsible for managing Chemistry, Manufacturing and Controls (CMC) activities supporting drug product registrations, lifecycle management and regulatory compliance throughout the product lifecycle.
Reporting directly to the CMC Coordinator, the CMC Senior Specialist will act as the focal point for the preparation and maintenance of CMC regulatory documentation, ensuring alignment between technical, quality and regulatory requirements while collaborating with internal functions and external partners.
Key responsibilities:
- Contribute to the definition of CMC strategies for new products development and identification of potential risks in collaboration with Pharmaceutical Development and Regulatory Affairs departments with particular focus on US FDA requirements.
- Collect and review scientific and technical data to support the preparation of high-quality CMC documentation (Modules 2.3 and 3) for new registrations, lifecycle management activities and Health Authority interactions.
- Collaborate with internal technical departments and external partners to ensure timely and compliant regulatory submissions.
- Review Change Controls related to manufacturing, analytical and quality changes, assess their impact on registered dossiers and ongoing submissions, and contribute to defining the appropriate regulatory strategy in collaboration with Regulatory Affairs.
- Support technology transfer and post-approval activities from a CMC perspective ensuring compliance with applicable guidelines.
- Contribute to continuous improvement of applicable know-how by attending courses, seminars and meetings.
Qualifications and skills:
- Bachelor's or Master's Degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry)
- At least 8–10 years of experience in the pharmaceutical industry, with significant experience in CMC, Regulatory Affairs, Pharmaceutical Development or technical regulatory support.
- Hands-on experience with sterile injectable liquid and semi-solid drug products, including aseptic, lyophilized and terminally sterilized products.
- Proven experience in the preparation and maintenance of CMC documentation (Modules 2.3 and 3) for registration dossiers, life-management activities and responses to Health Authorities.
- Strong knowledge of CMC requirements for ICH, EU, US, Swiss and international regulatory submissions including authority’s expectations related to process validation, stability and photostability studies, elemental impurities, extractables & leachables, nitrosamines and analytical methods validation.
- Experience in Change Control assessment and product lifecycle management.
- Experience working in cross-functional environments and coordinating activities involving Pharmaceutical Development, Manufacturing, Quality and Regulatory Affairs functions, as well as external partners (CMOs/CDMOs and regulatory stakeholders).
- Excellent command of written and spoken English.
- Excellent technical writing and ability to independently prepare CMC documentation.
- Strong planning and prioritization skills, with the ability to manage multiple activities and deadlines simultaneously.
- Strong analytical and problem-solving capabilities, with attention to detail and regulatory compliance.
Preference will be given to candidates of Swiss nationality and residents (Permit B -C)
We offer
Fulltime permanent employment in a young working environment and positive culture. Sintetica promotes diversity and gender equality.