MSAT Senior Manager

Our offerWe are seeking an innovative and experienced Program Manager to lead strategic initiatives in the Technical Operations organization. The scope of the role will include cross-functional management of continuous improvement efforts across process development, MSAT, manufacturing, and QC. The ideal candidate will have technical experience in late-stage CMC for cell therapy or biological drugs and accompanying technical project management expertise.Your missionKey Responsibilities:Owner of the client’s manufacturing process, product control strategy and process risk management.For drug product tech transfers: the facility fit assessment, the quotation process in collaboration with global BD and establishing the project timelines with the internal stakeholders.Lead new product introductions, process transfers and process improvement through the change control process.Single Point of Contact for the customer for all technical aspects and co-leader of joint tech transfer project teams. Collaborate with subject matter experts across technical disciplines (MSAT, analytical development, manufacturing, QC, etc.) to develop and implement process validation and monitoring plansProvide input in product specific equipment qualifications and develop process validation and testing control strategies in line with regulators and customer’s expectations.Ensure registration compliance, including the creation of source documents for dossier modules and review of regulatory CMC packages for IND/IMPD/MAA/Variations filings.Your profileSkills And CompetenciesTeam player with ability to drive projects and overcome resistance to change.Proven ability to manage complex CMC projects and their stakeholders.Excellent oral and written communication skills, including faculty with project management tools.Up to date knowledge and experience with cGMP compliance and relevant guidelines preferably for aseptic processing. Education and Experience:Master's/Ph.D. in Biology/Bioengineering/Biotechnology, or a related field.7+ years of experience in biotechnology project management and/or in roles of increasing seniority/leadership with a focus on aseptic processing.Experience working in a small/mid-sized pharma company preferred.Bilingual French and English.ContactIf you recognize yourself in this profile, feel free to send us your complete application at:rh-jura@adragos-pharma.com. 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 UsAdragos 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!