MSAT Oral Solid Drug Products CMVD SPCs Lead
We are a human-scale, international, and independent pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: "committed to therapeutic progress for the benefit of patients."
As a global leader in cardiology, we aim 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 goal.
Who are we? 22,000 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, motivated by the desire to care, to dare, to grow, and to commit to being useful to those in need.
Come and experience and contribute to our commitment #MovedByYou.
Location: Warsaw (Anpharm), Poland
Therapeutic Area: Cardio Metabolism & Venous Diseases (CMVD)
Expertise: Single-Pill Combinations (SPC) / Fixed-Dose Combinations (FDC)
Are you a recognized expert in Oral Solid Dosage (OSD) manufacturing sciences? Do you have a passion for technical excellence in multi-API formulations?
At SERVIER, we are driven by one mission: therapeutic progress to serve patient needs. As we accelerate our "2030 Ambition," our Manufacturing Science and Analytical Technology (MSAT) organization is playing a pivotal role in driving industrial transformation and ensuring the robustness of our global manufacturing footprint.
We are currently seeking a Global MSAT Oral Solids Drug Products CMVD SPCs Lead to join our team in Warsaw.
The Role:
Reporting to the Global Head of MSAT Oral Solid Drug Products, you will serve as the global technical authority for our CMVD Single-Pill Combination (SPC) portfolio. You will lead a team of Subject Matter Experts (SMEs) to ensure the seamless commercialization, scale-up, and lifecycle management of complex OSD products, including bilayer tablets, pellets-in-capsules, and mini-tablets.
Key Responsibilities:
- Technical Authority: Lead the manufacturing process knowledge for commercial OSD products, overseeing technology transfers, validation, and lifecycle management across internal and external sites.
- Scientific Rigor: Champion advanced process science frameworks, including Quality by Design (QbD) and Process Analytical Technology (PAT).
- Process Robustness: Implement Continued Process Verification (CPV) through risk-based monitoring of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
- Regulatory Strategy: Provide strategic technical input for CMC sections of regulatory submissions and interact with global Health Authorities (EMA, FDA, PMDA).
- Strategic Leadership: Collaborate with CMC counterparts to ensure effective technical transitions from development to commercial manufacturing.
Your Profile:
- Education: Advanced degree (PhD preferred, or MSc) in Pharmaceutics, Pharmaceutical Sciences, or Chemical Engineering.
- Experience: 15+ years in OSD process development and manufacturing sciences.
- Technical Expertise: Deep understanding of unit operations related to SPCs (wet/dry granulation, roller compaction, multi-layer compression, coating, and capsule filling for pellets/mini-tablets).
- Leadership: Proven track record of coaching technical teams and navigating global matrix organizations.
- Mindset: A growth-oriented leader passionate about building capabilities and driving continuous improvement in a transforming industrial environment.
Why Join SERVIER?
By joining SERVIER, you become part of an independent group governed by a non-profit foundation. This unique structure allows us to focus on long-term therapeutic progress and reinvest 20% of our non-generics turnover into R&D.
Ready to shape the future of MSAT? Apply now to contribute to the health of millions of patients worldwide.
We are committed to equal opportunities and developing talents in all their diversity. We value both experience and the desire to engage daily in contributing to therapeutic progress for the benefit of patients. If this offer resonates with you, seize this opportunity to meet us!