Job Title: Head of MSAT – Oral Solid Dosage
Location: England, UK
Department: Manufacturing / Technical Operations
Reports to: VP/Director of Technical Operations or Site Head
Company Overview
Our client is a leading pharmaceutical manufacturer/CDMO specialising in oral solid dosage forms, including high-volume commercial products and complex formulations. They are committed to quality, regulatory compliance, and continuous innovation.
Role Overview
The Head of MSAT (Manufacturing Science & Technology) will provide strategic and operational leadership for MSAT activities supporting commercial manufacturing, process improvements, and technology transfer for oral solid dosage products. This role will be responsible for ensuring robust, compliant, and scalable manufacturing processes across multiple product lines while supporting new product introductions (NPI) and continuous improvement initiatives.
Key Responsibilities
1. Leadership & Strategy
* Lead the MSAT team, providing guidance, coaching, and development.
* Define and execute the MSAT strategy aligned with site and corporate objectives.
* Serve as technical expert for oral solid dosage manufacturing processes.
2. Process Development & Technology Transfer
* Lead technology transfer from R&D to commercial manufacturing.
* Ensure process robustness, scalability, and reproducibility.
* Collaborate with R&D, QA, and Production teams to resolve manufacturing challenges.
3. Continuous Improvement & Innovation
* Identify opportunities for process optimization, yield improvement, and efficiency gains.
* Implement continuous improvement programs using Lean, Six Sigma, or similar methodologies.
* Support automation and digital transformation initiatives in manufacturing.
4. Compliance & Quality
* Ensure MSAT operations comply with cGMP, regulatory expectations, and internal quality standards.
* Support regulatory submissions and inspections, providing technical expertise and documentation.
* Manage change control, deviation investigations, and CAPA related to MSAT activities.
5. Cross-Functional Collaboration
* Partner with QA, Production, Supply Chain, and Engineering to drive operational excellence.
* Act as the technical point of contact for external stakeholders (customers, regulators, CDMOs).
Qualifications & Experience
Essential:
* Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
* Minimum 10–15 years’ experience in oral solid dosage manufacturing.
* Proven track record in MSAT, process development, and technology transfer.
* Strong knowledge of cGMP, regulatory standards (MHRA, EMA, FDA).
* Experience managing teams of technical professionals.
Desirable:
* Experience in CDMO or multi-product site environments.
* Knowledge of continuous manufacturing, high potency products, or OSD automation.
* Lean/Six Sigma or other process improvement certifications.
Skills & Competencies
* Leadership: ability to develop, motivate, and retain high-performing teams.
* Problem-solving: technical and analytical skills to troubleshoot complex manufacturing challenges.
* Communication: strong interpersonal and presentation skills for cross-functional collaboration.
* Project Management: ability to manage multiple technology transfer and optimization projects simultaneously.
* Strategic Thinking: aligning MSAT objectives with broader site and corporate goals.