Director / Senior Director, Late-stage Process and Analytical Development

My client is seeking a Director / Senior Director, Late-stage Process and Analytical Development that will play a pivotal role in orchestrating late-stage process development initiatives, steering towards licensure approval and eventual commercialization. This key position collaborates closely with CMC teams and executive leadership, aligning efforts with overarching objectives.

Responsibilities:

• Strategic Leadership: Provide strategic direction and leadership in late-stage process development activities, collaborating closely with cross-functional teams to align efforts with corporate goals and regulatory requirements.
• Process Optimization: Lead efforts to optimize late-stage manufacturing processes for drug substances and drug products, focusing on scalability, robustness, and efficiency to meet clinical and commercial demands.
• Technology Transfer: Oversee the successful transfer of late-stage processes to manufacturing sites, ensuring seamless integration and alignment with quality standards and regulatory expectations.
• Risk Management: Identify and mitigate potential risks associated with late-stage process development, implementing strategies to enhance process reliability and product quality while maintaining compliance with regulatory guidelines.
• Continuous Improvement: Drive continuous improvement initiatives within the late-stage process development function, leveraging data-driven insights and best practices to enhance efficiency, quality, and innovation.
• Analytical Method Development: Oversee and drive the design, optimization, and validation of analytical methods, employing state-of-the-art techniques to enable accurate and reliable assessment of product attributes.
• Analytical Testing: Coordinate analytical testing activities, including sample analysis, data interpretation, and troubleshooting to support process development, manufacturing, and regulatory submissions.
• Analytical Compliance: Ensure analytical methods comply with regulatory standards and industry best practices, maintaining alignment with current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) guidelines.
• Innovation: Explore innovative approaches and technologies to enhance analytical capabilities, fostering continuous improvement and staying at the forefront of analytical sciences.
• Method Transfer: Facilitate the transfer of analytical methods to internal and external testing laboratories, ensuring method robustness, reproducibility, and accuracy.
• Collaboration: Foster strong collaborations with internal stakeholders, including Research, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and Clinical Development teams, to facilitate cross-functional alignment and decision-making.
• Regulatory Compliance: Ensure adherence to regulatory requirements and industry standards throughout the late-stage process and analytical method development lifecycle, supporting the preparation and review of regulatory submissions as needed.
• Talent Development: Mentor and develop team members, providing guidance, support, and opportunities for growth to cultivate a high-performing and engaged workforce.
• Stay Current: Keep abreast of emerging trends, technologies, and regulatory requirements in process and analytical sciences, leveraging insights to drive continuous improvement and innovation.

• PhD or Master's degree in Chemical Engineering, Pharmaceutical Sciences, or related field with a minimum of 10 years of experience in late-stage process development within the biopharmaceutical industry.
• Proven track record of success in leading late-stage process development programs for biologic or cell-based therapies, from process optimization through technology transfer and commercialization.
• Deep understanding of cGMP regulations, quality systems, and regulatory requirements relevant to late-stage process development and manufacturing.
• Strong project management skills, with the ability to prioritize and manage multiple projects simultaneously in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.
• Strategic mindset with a focus on driving results, innovation, and continuous improvement to achieve organizational objectives.
• Leadership experience, with demonstrated ability to mentor, motivate, and develop a high-performing team.