Project Manager

Position: Associate Director, Parenteral Product Development

About the Role:

We are a leading organization in the biopharmaceutical industry, dedicated to advancing innovative biologic medicines. Our focus is on driving the development and commercialization of parenteral products, which include advanced monoclonal antibodies, antibody-drug conjugates (ADC), and other breakthrough therapeutic modalities.

Our team plays a central role in transforming promising pipeline projects from clinical stages to commercial success. We are seeking a motivated and visionary leader to oversee the transition of these products to our production site, helping ensure the successful scaling of new therapies.

Key Responsibilities:

As an integral member of our Process Development team, you will lead the transition of products from development to commercialization. This includes overseeing the final stages of process development, optimization, and validation to ensure our processes are scalable and ready for large-scale manufacturing. You will guide the creation of detailed data packages that support regulatory filings and contribute to the strategic direction of product development.

Your efforts will be crucial in shaping the future of our product portfolio, helping to secure regulatory approvals and supporting the successful launch of new treatments.

Responsibilities Include:

• Lead the process of transferring new products into our site, ensuring smooth transitions while maintaining high scientific and technical standards.
• Collaborate with global teams to optimize and validate processes for commercial-scale manufacturing.
• Contribute to the success of regulatory filings and ensure the timely market launch of innovative biologic therapies.

What We’re Looking For:

We seek a dynamic leader who excels in a fast-paced, constantly evolving environment. The ideal candidate will have the expertise and leadership to manage the technical transfer of pipeline products, ensuring all processes meet rigorous standards. You should be passionate about biologic innovations and committed to driving future success in the industry.

Qualifications and Skills:

• Proven leadership skills with experience in technical transfer and process optimization.
• Expertise in biologic product development, with a strong understanding of regulatory requirements and manufacturing processes.
• Ability to collaborate across diverse teams and drive results in a global environment.

If you’re excited about taking on a challenging leadership role and helping bring transformative therapies to market, we encourage you to apply!