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Director of Manufacturing and Process Development

3 months ago

London, United Kingdom FPSG Full time

Director of Manufacturing and Process Development - Small Molecule

Location: London

FPSG is working with a leading pharmaceutical company dedicated to developing life-saving medicines and innovative solutions for patients worldwide. We are seeking a highly skilled and experienced Director of Manufacturing and Process Development to lead our Chemistry API team. This is an exciting opportunity to drive innovation, optimize manufacturing processes, and ensure the highest quality standards for our API production.

Job Overview:

The Director of Manufacturing and Process Development - Chemistry API will be responsible for leading the development and implementation of manufacturing processes for our active pharmaceutical ingredients (APIs). You will lead a team of talented scientists and engineers, driving efficiency, scalability, and compliance throughout the manufacturing lifecycle.

Key Responsibilities:
  1. Develop and implement strategic plans for API manufacturing, ensuring alignment with company goals and regulatory requirements.
  2. Lead a team of scientists, engineers, and technicians in the design, optimization, and scale-up of API manufacturing processes.
  3. Drive innovation and continuous improvement initiatives to enhance process efficiency, yield, and product quality.
  4. Collaborate cross-functionally with Research & Development, Quality Assurance, Regulatory Affairs, and Supply Chain teams to ensure successful technology transfer and commercialization.
  5. Provide technical expertise and guidance on process development, troubleshooting, and optimization activities.
  6. Establish and maintain a culture of safety, compliance, and good manufacturing practices (GMP) within the manufacturing facility.
  7. Lead and oversee validation activities for manufacturing processes, equipment, and cleaning processes.
  8. Manage budgetary responsibilities, including resource allocation, capital expenditures, and cost control measures.
  9. Stay updated on industry trends, regulatory changes, and emerging technologies in API manufacturing.
Qualifications:
  • 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.

We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process

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