Our offer
We are seeking an MSAT Manager capable of driving projects in the Contract manufacturing Organization. The scope of the role will include cross-functional management of new product introductions and continuous process improvement initiatives. The ideal candidate will have late-stage process development expertise, preferably aseptic processing and technical project management experience.
Your mission
Key Responsibilities:
1. Responsible for several client products.
2. For drug product clinical trial supply and tech transfers: the facility fit assessment, the quotation process in collaboration with global BD and establishing the project timelines with the internal stakeholders.
3. Single Point of Contact for the customer for the deliverables, timelines, risks and technical aspects.
4. Collaborate with subject matter experts across functions (MSAT, analytical development, manufacturing, QC, etc.) to implement project plans.
5. Provide input to product-specific equipment qualifications, process validation strategy and testing control strategies in line with regulators' and customers' expectations.
6. Author or contributor of source documents for dossier modules and reviewer of regulatory CMC packages for IND/IMPD/MAA/Variations filings.
Your profile
Skills And Competencies
7. Team player with ability to drive projects and overcome resistance to change.
8. Proven ability to identify risks and manage complex projects with their stakeholders.
9. Excellent oral and written communication skills, including faculty with project management tools.
10. Up to date knowledge and experience with cGMP compliance and relevant guidelines preferably for aseptic processing.
Education and Experience:
11. Master's/Ph.D. in Biology/Bioengineering/Biotechnology, or a related field.
12. 5+ years of experience in pharma project management and/or roles with increasing leadership in process development with at least 1-2 years in aseptic processing and/or process transfers.
13. Experience working in a small to mid-sized pharma company is an advantage.
14. Bilingual French and English.
Contact
If you recognize yourself in this profile, feel free to send us your complete application at: rh-- We thank all candidates for their interest, but only those selected for an interview will be contacted. Adragos Pharma - BACCINEX SA – Rue de la Source 3 – 2822 Courroux – Switzerland.
About us
Adragos Pharma is a reliable Contract Development and Manufacturing Organization (CDMO) headquartered in Munich, Germany. We provide comprehensive development and manufacturing services for drug products, including sterile and non-sterile liquids, solids, and semi-solids. Our expertise also covers biologicals, orphan drugs, clinical trials, fill-and-finish, and lyophilization, offering end-to-end solutions from product development to commercial supply.
With production sites in Germany, France, Greece, Norway, Japan, and Switzerland, we ensure high-quality manufacturing across all stages of the drug development process.
Founded in 2020, Adragos Pharma has rapidly grown through an ambitious buy & build strategy, supported by FSN Capital. With a team of over 900 professionals, we are expanding our operations across Europe, North America, and Japan to become a global leader in the CDMO sector.
As a key player in the pharmaceutical industry, CDMOs like Adragos produce 25% of all drugs globally, ensuring access to essential medications. With increasing healthcare demands, we continue to innovate and set new standards in drug manufacturing.
You want to be part of our dynamic growth? Then apply now