Client Program Manager - Mabxience

Specific Responsabilities

Support global biosimilars projects executed with CDMO model across upstream/downstream process development, analytical development, drug substance, and drug product manufacturing.
Coordinate project activities between internal teams (CMC, Quality, Regulatory, Supply Chain as applicable) and external partners.
Develop and maintain CDMO-focused project plans, timelines, milestones, and deliverables.
Track progress, risks, issues, and dependencies related to manufacturing and escalate as needed.
Organize and facilitate project meetings with partners, including governance, technical, and operational forums.
Ensure compliance with GMP, quality agreements, and regulatory expectations (EMA, FDA, ICH) in alignment with QA.
Support tech transfer, validation, and manufacturing readiness activities.
Prepare project documentation, dashboards, and reports related to CDMO model performance.
Create and maintain project budget. Monitor adherence to the approved product schedule and prepare amendments whenever a new activity or change is identified.
Liaise with finance and commercial team for invoicing of initiated/completed activities.
The Program Manager is accountable for the success of the client programs assigned to them

Requirements

Education: Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering or related field (Master's preferred)
Languages: Fluent English (spoken and written) is mandatory, as the role operates in a global cross-functional and multicultural environment. Fluency in Spanish is also required
Experience: +10 years of experience in pharmaceutical or biotechnology development or manufacturing, preferably involving CDMOs
Specific Knowledge: Basic understanding of biosimilars CMC development and external manufacturing models. Experience working with cross-functional and external partner teams. Proficiency in Project management tools (e.g.: MS Project, Smartsheet, Planisware). PMP or equivalent certification is a plus
Travel: Occasional (within Spain or Argentina and occasionally to customer's locations)

Personal Skills