Head, Drug Product Smart Lab

What You Will Achieve

As the Head of DPDS SmartLab, you will spearhead the digital transformation of our formulation R&D labs, fostering a culture of innovation, operational excellence, and scientific rigor. You will be responsible for the strategic direction, implementation, and optimization of SmartLab technologies across formulation development laboratories, ensuring seamless integration with cross-functional teams. Your leadership will be key to advancing our next generation laboratory practices, enhancing material assessment and characterization approaches to further enable integration with computational models to achieve increased efficiency in formulation and process development workflows. Additionally, this position will lead a group of scientists and engineers in delivering drug product development programs from clinical stage to registration and initial commercial manufacture.

How You Will Achieve It

• Work collaboratively across the PSSM organization, develop and execute the strategic vision for the SmartLab initiatives in drug product design laboratories, driving the adoption of digital, automated, and data-centric laboratory practices, including design and implementation of new science of scale tools to further accelerate development of predictive and computational models.

• Drive design and implementation in laboratory automation and high-throughput experimentation to accelerate drug product formulation and process optimization.

• Collaborate across partner lines to ensure data integrity, traceability, compliance and knowledge management throughout the drug product formulation development lifecycle.

• Interface with external partners, technology vendors, and academic collaborators to identify and harness emerging SmartLab technologies and best practices.

• Serve as the Drug Product Design accountable manager for development programs at various stages.  Successfully lead teams to achieve program milestones from clinical to initial commercial launch.

• Serve as a subject matter expert in formulation and process development for solid oral dosage forms, including immediate release and modified release dosage forms.

• Develop strategic collaborations with academic and industrial researchers for addressing gaps in fundamental or applied science related to drug product development.

• Lead a group of 8~12 scientists/engineers/ Elli contractors and support colleague career growth and scientific advancement.

QUALIFICATIONS

Must Have

• PhD with 7+ years of experience in drug product design and development OR BS degree with 10+ years of experience in drug product design and development.

• MBA/MS degree with 9+ years of experience in drug product design and development.

• Experience with SmartLab technologies to support drug product design, including laboratory digitalization and automation.

• Broad experience with the various disciplines of drug product design, including materials science, biopharm, manufacturing science and commercial manufacture of solid oral dosage forms

• Experience working independently and collaboratively in a laboratory environment

Nice to Have

• Proven expertise in SmartLab technologies, including laboratory digitalization, automation, AI/ML, and data integration platforms.

• Experience with external partnership management, vendor evaluation, and technology scouting is highly desirable.

• Demonstrated leadership in cross-functional environments and experience in digital transformation and continuous improvement.

• Adaptability and resilience in navigating a rapidly evolving scientific and technological landscape.

• Demonstrated successful leadership of multi-disciplinary teams to achieve program milestones from First in Human / First in Patient studies to clinical manufacture to drug product registration and initial commercial launch

• Experience in designing and conducting hypothesis driven laboratory experiments, building on knowledge in material characterization, science of scale tools and technology transfers.

• Strong track record of a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

• In-depth knowledge of pharmaceutical development processes, regulatory requirements and quality systems.

• Strong project and portfolio management skills, with an ability to prioritize, delegate, and deliver results in fast-paced, matrixed organizations.

• Exceptional com