Walker Cole International is seeking a dynamic Head of Formulation to join a growing pharmaceutical CDMO in the South of England. This is an exciting opportunity for an experienced leader in formulation development, with a focus on driving the successful development and commercialization of oral solid dosage forms, while overseeing project management, team leadership, and innovation in pharmaceutical drug product manufacturing.
Key Responsibilities:
- Formulation Development: Design, plan, and develop robust formulations from concept to commercial launch, ensuring required claims, novel technologies, excipient/packaging compatibility, product performance, physical characteristics, physicochemical stability, sustainability, risks, and costs are considered.
- Project Management: Manage multiple projects simultaneously, ensuring methodical experimental design, meticulous execution, and precise data analysis, guaranteeing timely milestone completion and smooth transition from development to commercialization.
- Team Leadership and Mentorship: Lead and mentor a small team of Formulation Chemists, providing direction, training, and development opportunities, ensuring team members grow their skills and maintain training records.
- Collaboration & Stakeholder Communication: Act as the main point of contact for development projects, liaising with clients, internal teams, and stakeholders to ensure effective communication and smooth project execution.
- Process Innovation and Optimization: Drive innovation in formulation techniques and continuously seek improvements to enhance product quality, efficiency, and sustainability.
- GMP Compliance & Regulatory Adherence: Ensure all formulations meet the highest GMP compliance and regulatory requirements, applying Quality by Design (QbD) principles throughout the development processes.
- Documentation and Reporting: Document all R&D activities accurately and in a timely manner, ensuring that batch records, stability reports, development protocols, and other necessary documents meet regulatory standards.
- Product and Technology Transfer: Collaborate with cross-functional teams to manage the seamless transfer of new formulations from development to production and commercialization.
Required Experience and Skills:
- A degree in Pharmaceutical Sciences, Chemistry, or a related field.
- Several years of experience in formulation development, particularly with oral solid dosage (OSD) forms, and a solid background in pharmaceutical CDMO environments.
- Proven experience in leading formulation projects from concept through to commercial launch, focusing on novel technologies and excipient/packaging compatibility.
- Strong project management skills, with the ability to manage multiple concurrent projects while maintaining high standards of execution.
- Leadership experience with the ability to manage and mentor a small team of scientists, ensuring the development of their skills and expertise.
- In-depth knowledge of GMP standards and regulatory compliance in pharmaceutical formulation development.
- Expertise in drug product manufacturing techniques, such as granulation, compression, coating, and other key OSD manufacturing processes.
- Excellent communication and organizational skills, with the ability to collaborate effectively across teams and engage with clients and stakeholders.
Formulation | Pharmaceutical | CDMO | OSD | GMP | Quality by Design | Drug Product Manufacturing Techniques | Oral Solid Dosage | Project Management | Team Leadership | Regulatory Compliance | Product Development | Technology Transfer | Granulation | Compression | Coating | Pharmaceutical Sciences