MSAT Manager

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:• Responsible for several client products.
• 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.  
• Single Point of Contact for the customer for the deliverables, timelines, risks and technical aspects. 
• Collaborate with subject matter experts across functions (MSAT, analytical development, manufacturing, QC, etc.) to implement project plans. 
• Provide input to product-specific equipment qualifications, process validation strategy and testing control strategies in line with regulators’ and customers’ expectations.
• 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
• Team player with ability to drive projects and overcome resistance to change.
• Proven ability to identify risks and manage complex projects with 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.
• 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.
• Experience working in a small to mid-sized pharma company is an advantage.
• Bilingual French and English.

Contact:
If you recognize yourself in this profile, feel free to send us your complete application at:
[email protected]. 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.