Director of Manufacturing - Drug Substance
Director of Manufacturing - Drug Substance
Are you prepared to take on a transformative leadership role in pharmaceutical manufacturing? Our client, a global leader in the pharmaceutical industry, is seeking an accomplished and visionary Director of Manufacturing to lead their biologics operations. This is a unique opportunity to join an innovative and forward-thinking organization, contributing to groundbreaking clinical and commercial manufacturing efforts that directly impact global health and well-being. Be at the forefront of driving excellence in drug substance manufacturing and shaping the future of biologics production.
Role Highlights:
- Oversee end-to-end manufacturing operations with a team comprising over 80 skilled professionals, ensuring optimal efficiency, collaboration, and adherence to the highest operational standards.
- Lead and manage biologics manufacturing with a specific focus on drug substance production, including traditional upstream biologics processes such as monoclonal antibodies (mAbs), recombinant proteins, and other advanced therapeutics.
- Develop and execute strategic plans for both clinical and commercial manufacturing, ensuring seamless integration of innovative methodologies to drive operational excellence and product quality.
- Leverage extensive expertise in Contract Development and Manufacturing Organizations (CDMOs) to enhance process optimization, scalability, and compliance with industry regulations.
- Serve as a key driver in the development of innovative drug substance pipelines, ensuring alignment with corporate objectives and industry-leading best practices.
What We're Looking For:
- Extensive and proven expertise in pharmaceutical manufacturing, with a minimum of 12+ years of experience specifically in biologics manufacturing, focusing on drug substance production. Experience in traditional upstream biologics, including monoclonal antibodies (mAbs), recombinant proteins, and other complex biologics, is essential.
- Demonstrated success in managing large-scale teams, fostering a culture of collaboration, growth, and operational excellence. Experience managing teams of 80+ total reports is a critical component of this role.
- Comprehensive knowledge of clinical and commercial manufacturing processes, with the ability to seamlessly transition between the two while maintaining stringent quality and compliance standards.
- A track record of leadership in high-performing environments, with exceptional strategic decision-making capabilities and the ability to inspire teams to achieve ambitious goals.
- Experience working within or alongside CDMOs, with a strong understanding of the complexities of contract manufacturing and development partnerships.
- A bachelor's degree is required, with advanced degrees or additional certifications in related fields considered a strong advantage.
The ideal candidate will bring unparalleled expertise in drug substance biologics manufacturing, coupled with a passion for driving innovation and achieving industry-leading results. Your leadership and strategic vision will be instrumental in propelling our client's mission forward, enabling the organization to make a profound impact on global health initiatives.
This is a rare opportunity to join a pioneering team and contribute to a transformative era in pharmaceutical manufacturing. If you are a results-driven professional with a commitment to excellence, we invite you to apply and explore how you can leave a lasting legacy in this vital industry.
Take the next step in your career and lead the charge in shaping the future of biologics manufacturing. Apply now to become an integral part of this groundbreaking organization.
FAQs
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