Senior Formulation Manager

The Senior Formulation Manager is a Strategically Important Role and will Report Directly to the Chief Scientific Officer.  The Successful Applicant will be Responsible for the Management and Direction of the Ongoing Development Work within the R&D Team

ROLE

• Lead Formulation Development, Process Development, Process Optimisation, Scale-Up and Clinical Manufacturing Activities for All Development Projects
• Source of Technical Expertise in the Company, Keeping Abreast of Relevant Developments
• Review and Authorise Reports/Documents eg Product Development Reports
• Author of Scientific Publications and Presentation at Conferences and Scientific Events
• Support Patent Filing and Prosecution
• Work with the Clinical Review Board to Identify Product Opportunities for the Platform Technologies
• Work Closely with the Clinical Team in respect of Clinical Proof of Concept Studies on Novel Formulations
• Conduct Briefings and Technical Meetings for Senior Management and Representatives

REQUIRED (Essential)

• PhD, BPharm or BSc (Pharmacy, Chemistry and/or Related Subjects)
• Minimum 5 Years’ Practical Experience in Design of Solid Oral Dosage Forms
• Knowledge, Practical Experience and Solutions for API and Formulation Challenges
• Solid Understanding of Controlled Release Drug Delivery Technologies
• Knowledge of Drug Development Processes and Regulatory Requirements
• Experience in Robust Product Development and Implementation of QbD Principles
• Proven Team Management Experience
• Excellent Communication Skills, Written, Spoken and Presentation

REQUIRED (Desirable)

• Knowledge of EU/FDA Regulatory Guidance’s, ICH Guidelines and Requirements for Regulatory Submissions
• Experience of Technology Transfer, Scale Up and GMP Manufacture

REMUNERATION

• Basic Salary of £40K Per Annum

RESPOND

• Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV