Director / Senior Director, Late-stage Process and Analytical Development
7 days ago
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.
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