Senior Manager - Late-Stage Process Transfer & Validation

Job Title: 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

• Fluent in English; 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