MSAT Oral Drug Product Onco/Neuro Expert

Servier; Suresnes; Ibrido; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Servier invites applications for an MSAT Oral Solid Drug Product Onco/Neuro Expert to support manufacturing and lifecycle management of Oncology and Neurology oral solid products across internal and external sites.

Eligible for Europe-based candidates (France, Poland, or Ireland) with up to 20% travel. You will contribute to process optimization, CPV, tech transfers, and regulatory submissions within a collaborative MSAT team.

Competenze

• Bachelor’s degree with 6–8+ years in drug product formulation and process development, or MSc/PhD with relevant industry experience.
• Experience in regulatory submissions and lifecycle management.
• Strong knowledge of oral solid dosage manufacturing and CPV.

Mansioni

• Provide technical oversight of manufacturing processes for assigned oral solid commercial products at internal sites and external CMOs.
• Lead internal cross-functional Technical Teams for drug product topics.
• Lead or support deviation investigations, root cause analyses, and CAPA definitions.
• Maintain and oversee CPV and process monitoring for assigned products.
• Build and maintain MSAT knowledge repository for products and processes.
• Lead or support tech transfers, scale changes, PPQ, and launch readiness.
• Conduct process risk evaluations and FMEA as part of lifecycle management.
• Support regulatory CMC submissions and QA/regulatory interactions.
• Suggest PAT tools and in-line monitoring for process assurance.
• Stay current with MSAT best practices and industry trends.

Conoscenze

Oral solids

Formulation

GMP/ICH

Statistics

Tech transfers

Regulatory docs

CAPA

Cross-functional

Project management

Communication

Formazione

Bachelor's Degree in Pharmaceutical Sciences, Chemical Engineering or related technical field

Strumenti

Minitab

JMP

Descrizione del lavoro

We are a human-sized, international, and independent pharmaceutical group, governed by a Foundation. Our unique model is a source of pride, but above all, it allows us to fully serve our mission: “Committed to therapeutic progress for the benefit of patients.”

Today, a global leader in cardiology, we have chosen to become a focused and innovative player in oncology by 2030, targeting hard-to-treat cancers and dedicating more than 70% of our R&D budget to this area. We are committed to equal opportunities and the development of talent in all its diversity. We value both experience and the willingness to engage daily to contribute to therapeutic progress for the benefit of patients. If you see yourself reflected in this offer and these few lines, seize the opportunity to meet us. We pursue this challenge alongside the development of our generics business, ensuring access to quality care for all, at a lower cost.

We are committed to equal opportunities and the development of talent in all its diversity.

Who are we? More than 20,000 passionate individuals from over 50 nationalities, driven by an entrepreneurial spirit. Every day, we move forward with and for patients, with and for our teams, guided by the desire to care, to take risks, to grow, and to commit ourselves to be useful to those in need.

Position based in Europe (France or Poland or Ireland) with domestic and international travel up to 20%.

Within Servier Industry, the Manufacturing Science and Analytical Technology (MSAT) organization plays a key role in driving technical excellence, industrial transformation, and lifecycle management — enabling manufacturing robustness, quality, and compliance across all product modalities and technologies.

Role Summary

The MSAT Oral Solid Drug Product Onco/neuro Expert serves as the technical subject matter expert for Onco/Neuro Oral Solid products. This role provides scientific and process expertise to support the manufacturing and lifecycle management of Oncology and Neurology related oral solid drug products across internal and external manufacturing sites.

Primary Responsibilities

Technical Oversight of Internal and External Manufacturing Processes

• Provide technical oversight of manufacturing processes for assigned oral solid commercial products at Servier internal sites in collaboration with Site MSAT and at external partners (CMOs) as part of Virtual Plant Teams
• Lead internal cross-functional Technical Teams to facilitate drug product related technical topics in collaboration with other functions
• Lead or support deviation investigations, root cause analyses, and CAPA definition for process-related issues, ensuring robust closure and knowledge transfer.
• Maintain and oversee process monitoring and Continued Process Verification (CPV) for assigned commercial products across manufacturing sites.
• Build and maintain MSAT knowledge repository for assigned commercial products and processes

Technology Transfer and Lifecycle Management

• Lead or support tech transfers, scale changes, PPQ, and launch readiness activities across global sites.
• Conduct and document process fit assessments, risk evaluations, and FMEA as part of the lifecycle management strategy.
• Participate in process optimization efforts, including yield, throughput, and quality performance improvements across the network.

CMC and Regulatory Support

• Author or review CMC-related sections of regulatory submissions (e.g., post-approval changes, variations, new market filings as needed).
• Support Regulatory CMC in responding to health authority questions related to commercial manufacturing processes and controls.
• Ensure manufacturing and validation strategies are aligned with GMP, ICH, and global regulatory expectations.

Subject Matter Expertise and Continuous Improvement

• Support implementation and optimization of manufacturing processes and related control/sampling strategies (e.g., granulations, compression, coating, pellet layering, capsule filling, segregation control measures).
• Specify and support qualification/optimization of tooling and equipment
• Anticipate scale-dependent challenges and define scale-up acceptance criteria, equivalence studies and narrative for regulatory dossiers.
• Recommend and deploy PAT tools where beneficial (NIR, weight/force monitoring, in-line content estimation) for real-time or near-real-time assurance of processes
• Perform risk and criticality assessments to identify gaps and define improvements in line with quality, regulatory, and business expectations.
• Stay current with industry trends, scientific literature, and evolving technologies related to OSD manufacturing and MSAT best practices.

Education :

Bachelor’s Degree in Pharmaceutical Sciences, Chemical Engineering or related technical field with minimum of 8 years relevant experience, or preferably a Masters or PhD in Pharmaceutical Sciences, Chemical Engineering or related technical field with a minimum of 6 years of relevant experience in drug product formulation and process development and manufacturing support including experience with regulatory submissions

Technical skills :

• In-depth knowledge of formulation concepts/techniques across immediate-release and extended-release oral solid dosage forms and relevant manufacturing processes,
• In-depth knowledge of primary container closure components used for oral solid dosage forms
• Expertise in use/application of basic statistical methodologies and software (e.g., Minitab, JMP or equivalent)
• Expertise in use/application of variety of problem-solving tools
• Experience leading or supporting tech transfers, deviation investigations, change controls, and regulatory documentation.
• Strong knowledge of GMP, ICH guidelines, and regulatory submission expectations for commercial products.
• Comfortable working in a global matrixed team with cross-functional collaboration across Quality, Manufacturing, Supply Chain, and Regulatory.
• Strong ability to strategically plan, organize, and manage multiple projects simultaneously
• Excellent written/oral communication and presentation skills
• Excellent communication and documentation skills; able to interface effectively with internal stakeholders and external partners.
• A continuous improvement and learning mindset, aligned with Servier’s strategic direction and patient-first values.

We are committed to equal opportunities and the development of talent in all its diversity. We value both experience and the willingness to engage daily to contribute to therapeutic progress for the benefit of patients. If you see yourself reflected in this offer and these few lines, seize the opportunity to meet us.

We are committed to equal opportunities and the development of talent in all its diversity.