Senior Manager – Late-Stage Process Transfer & Validation

Barrington James; Castilla-La Mancha; Híbrido; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

An innovative mid-sized CDMO in Spain is seeking a Senior Manager for Late-Stage Process Transfer & Validation. This pivotal role involves leading technology transfer and validation activities for complex drug products, ensuring compliance with GMP standards. The successful candidate will collaborate with cross-functional teams and clients, driving high-impact projects in a dynamic environment. With a focus on injectables and aseptic fill-finish, this position offers autonomy, visibility, and the chance to shape the future of drug product development. Join a vibrant team and make a real difference in the pharmaceutical industry!

Servicios

Competitive salary

Bonus

Relocation support

Hybrid working options

Collaborative culture

Direct access to senior leadership

Formación

• 7+ years of experience in pharmaceutical manufacturing or process development.
• Expertise in late-stage development, tech transfer, and process validation.

Responsabilidades

• Lead late-stage technology transfer of drug product manufacturing processes.
• Oversee process validation and manage project plans and risk assessments.

Conocimientos

Pharmaceutical Manufacturing

Process Development

Project Management

Regulatory Compliance

Technical Transfer

Communication

Educación

Degree in Pharmacy

Degree in Chemical Engineering

Degree in Biotechnology

Descripción del empleo

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