Director of Manufacturing and Process Development
FPSG
- London
- £100,000-120,000 per year
- Permanent
- Full-time
- Develop and implement strategic plans for API manufacturing, ensuring alignment with company goals and regulatory requirements.
- Lead a team of scientists, engineers, and technicians in the design, optimization, and scale-up of API manufacturing processes.
- Drive innovation and continuous improvement initiatives to enhance process efficiency, yield, and product quality.
- Collaborate cross-functionally with Research & Development, Quality Assurance, Regulatory Affairs, and Supply Chain teams to ensure successful technology transfer and commercialization.
- Provide technical expertise and guidance on process development, troubleshooting, and optimization activities.
- Establish and maintain a culture of safety, compliance, and good manufacturing practices (GMP) within the manufacturing facility.
- Lead and oversee validation activities for manufacturing processes, equipment, and cleaning processes.
- Manage budgetary responsibilities, including resource allocation, capital expenditures, and cost control measures.
- Stay updated on industry trends, regulatory changes, and emerging technologies in API manufacturing.
- PhD in Chemistry, Chemical Engineering, or related field. MBA or equivalent business experience is a plus.
- Minimum of 10 years of experience in pharmaceutical manufacturing, with a focus on Chemistry API.
- Proven track record of leadership in process development, scale-up, and optimization of API manufacturing processes.
- Extensive knowledge of GMP regulations, ICH guidelines, and global regulatory requirements for API production.
- Strong project management skills, with experience leading cross-functional teams and managing complex projects.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively at all levels of the organization.
- Experience with process analytical technology (PAT), statistical analysis, and DOE methodologies.
- Demonstrated success in driving innovation, cost reduction initiatives, and operational excellence in a manufacturing environment.
- Experience in managing teams, mentoring staff, and fostering a culture of professional development and growth.