Senior Manager – Late-Stage Process Transfer & Validation
Location : Spain (Hybrid / Flexible Options Available)
Company : Confidential – Mid-Size CDMO Specializing in Drug Product Development & Manufacturing
About Us
We are a dynamic, mid-sized Contract Development and Manufacturing Organization (CDMO) located in Spain, supporting global pharmaceutical and biotech clients from clinical development through commercial supply. With a strong focus on injectables, aseptic fill-finish, and complex drug products, we blend scientific excellence with operational agility.
As we continue to grow our late-stage and commercial manufacturing capabilities, we're seeking a passionate and experienced Senior Manager of Process Transfer & Validation to lead key tech transfer and validation programs, ensuring seamless scale-up and GMP readiness.
Your Role
As Senior Manager, Late-Stage Process Transfer & Validation, you will be the technical lead for process scale-up, technology transfer, and validation activities for late-phase and commercial drug products. You’ll collaborate cross-functionally with internal teams and client stakeholders to ensure robust, compliant, and timely execution of tech transfer and validation strategies.
Key Responsibilities
* Lead late-stage technology transfer of drug product manufacturing processes (e.g., aseptic fill-finish, lyophilization, complex formulations)
* Oversee process validation, including PPQ campaign planning and execution
* Develop and manage project plans, risk assessments, and validation master plans
* Act as primary technical interface with clients during late-phase development and transfer
* Work closely with MSAT, Quality, Regulatory, and Operations to ensure GMP-compliant implementation
* Author and review protocols, reports, and regulatory documentation (e.g., BLA / MAA sections)
* Support continuous improvement and troubleshooting of existing processes post-validation
Qualifications
* Degree in Pharmacy, Chemical Engineering, Biotechnology or related field (MSc or PhD preferred)
* 7+ years of experience in pharmaceutical manufacturing or process development, ideally in a CDMO or multi-product GMP environment
* Demonstrated expertise in late-stage development, tech transfer, and process validation
* Strong knowledge of EU GMP, ICH, EMA / FDA guidelines
* Excellent communication and project management skills
Spanish is a strong plus.
What We Offer
* A key leadership role in a growing international CDMO
* Autonomy, ownership, and visibility in high-impact programs
* Collaborative, agile culture with direct access to senior leadership
* Competitive salary, bonus, and relocation support (if applicable)
* Beautiful location in Spain with hybrid working options
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