Role Summary
Associate Director within CMC BioDPDM, leading a global team focused on fast-paced, high-quality drug development from early phase through commercialization across multiple modalities. Responsibilities include formulation and process development, in-use study design, and tech transfer to clinical and commercial manufacturing sites, with collaboration across manufacturing and process engineering.
Responsibilities
- Lead a team of 4-7 staff in formulation and process development activities across modalities.
- Interface with manufacturing and other cross-functional partners.
- Serve as a leader in the formulation and process development group facilitating the development of new tools and ways of working.
- Be responsible for planning, executing, and supporting formulation development, process development, and tech transfer of programs to clinical and commercial manufacturing sites.
- Bring a strong understanding of formulation development and in-use study design to contribute to new modalities and ways of working.
Qualifications
- Experience: Strong formulation development knowledge, experience in development of multiple modalities, experience in in-use study design principles, knowledge of biologics manufacturing and process development.
- Soft and technical skills: Team and project oriented with strong motivation and work ethic, strong communication and presentation skills.
- Education: PhD in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Molecular Biology, Bioengineering, or a related discipline with >7 years of relevant laboratory experience or an MS with >10 years.
- Languages: English