CMC Senior Specialist - Mendrisio site (Ticino) — Sintetica SA
- Location
- Mendrisio
- Contract
- other
- Posted
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Role overview
CMC Senior Specialist
Mendrisio site (Ticino) — Sintetica SA, Mendrisio (TI). CMC Senior Specialist Mendrisio site (Ticino)
We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them.
- CMC Senior Specialist
- Mendrisio site (Ticino) — Sintetica SA, Mendrisio (TI). CMC Senior Specialist Mendrisio site (Ticino)
- 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.
- and skills:
- Bachelor's or Master's Degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry)
Main responsibilities
- 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.
Key requirements
- 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.
What the company offers
- 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.
Additional details
- Mendrisio site (Ticino) — Sintetica SA, Mendrisio (TI). Mendrisio site (Ticino)
- 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. Qualifications and skills:
- Preference will be given to candidates of Swiss nationality and residents (Permit B -C)
Notes and original content
- Mendrisio site (Ticino) — Sintetica SA, Mendrisio (TI).
- Mendrisio site (Ticino)
- 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:
- Qualifications and skills:
Questions about this listing
What salary does Sintetica SA offer for this role?
Sintetica SA lists CHF 68'000 - 103'000 gross per year for this position in Mendrisio. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Sintetica SA offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Sintetica SA during the application process, since these details can vary by role even within the same contract category.
Do I need the G permit to apply for this role in Ticino as an Italian cross-border worker?
Yes, if you are resident in Italy within the 20 km border zone. The Swiss employer files the G-permit application at the Ticino cantonal migration office after the contract is signed — first issuance takes 2-6 weeks, then automatic yearly renewal for as long as the employment continues. Weekly return to your Italian home is required to keep the status.
How do I apply for this position at Sintetica SA?
Use the "Apply now" button on this page — it links directly to Sintetica SA's original listing at app.ncoreplat.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
