Position Overview:
We are seeking a highly experienced and dynamic Director of Process Chemistry to join our innovative biotechnology company. The successful candidate will lead the Process Chemistry team, focusing on the development, optimization, and scale-up of chemical processes for the production of small molecules, intermediates, or other therapeutic candidates. This pivotal role requires strong scientific leadership, strategic vision, and a collaborative mindset to drive the success of our pipeline and contribute to our mission of advancing transformative therapies.
Key Responsibilities:
- Provide strategic direction for the Process Chemistry function, aligning with organizational goals and R&D priorities.
- Build and lead a high-performing team of chemists, fostering a culture of innovation, excellence, and collaboration.
- Identify and implement cutting-edge technologies and methodologies to enhance process efficiency and scalability.
- Oversee the design, development, and optimization of robust and scalable chemical processes for active pharmaceutical ingredients (APIs) and intermediates.
- Ensure seamless transfer of processes from discovery to development, and from development to manufacturing.
- Evaluate and mitigate risks associated with process development, including environmental, safety, and quality considerations.
- Manufacturing and Scale-Up:
- Partner with Contract Development and Manufacturing Organizations (CDMOs) and internal teams to support technology transfer, scale-up, and manufacturing campaigns.
- Troubleshoot and resolve challenges during manufacturing processes, ensuring compliance with regulatory requirements.
- Collaboration and Cross-Functional Integration:
- Collaborate with medicinal chemistry, analytical chemistry, formulation, regulatory, and quality teams to ensure alignment of development efforts.
- Act as the process chemistry subject matter expert (SME) in multidisciplinary project teams.
- Compliance and Documentation:
- Maintain up-to-date knowledge of regulatory guidelines and industry standards for process chemistry and manufacturing.
- Oversee the preparation and review of technical documents, including batch records, process descriptions, and regulatory submissions.
Qualifications:
- Education: Ph.D. in Organic Chemistry, Process Chemistry, or a related field; advanced degrees strongly preferred.
- Experience:
- Minimum of 10 years of experience in process chemistry, with a track record of success in the biotechnology or pharmaceutical industry.
- Proven expertise in scaling up chemical processes from lab to manufacturing scale.
- Strong understanding of regulatory requirements for API production and Good Manufacturing Practices (GMP).
- Skills:
- Exceptional leadership, communication, and team-building skills.
- Proficiency in process analytical technologies (PAT) and modern synthetic methodologies.
- Ability to solve complex scientific problems and manage multiple priorities in a fast-paced environment.
Preferred Qualifications:
- Experience working with CDMOs and managing external partnerships.
- Familiarity with emerging trends in green chemistry and sustainability in pharmaceutical manufacturing.
