Are you passionate about biologics and ready to lead impactful projects in drug substance manufacturing? We’re looking for an Associate Director to join our Enterprise Go To Market team within Biologics Science and Technology. In this role, you will be a key scientific and technical leader, guiding upstream and downstream operations, leading investigations, and supporting our teams with your expertise.
Bring energy, knowledge, innovation to carry out the following:
- Lead the design, development, characterization, and technical transfer of biologics drug substance processes, ensuring on-time delivery that meets quality, scientific, and regulatory standards.
- Manage detailed planning, risk assessments, and documentation for technology transfers, including regulatory filings and approvals.
- Collaborate closely with internal teams across Research & Development, Commercialization, Operations, Quality, Regulatory, and Supply Chain, as well as external manufacturing partners.
- Support continuous improvement initiatives and share knowledge across teams.
- Uphold current Good Manufacturing Practices (cGMP) and promote a safe, compliant work culture.
- Build strong, inclusive partnerships across diverse teams and sites.
- Present progress and results at key governance meetings.
What skills you will need:
In order to excel in this role, you will more than likely have:
- A Bachelor’s degree in Biological Sciences, Chemical Engineering, Bioengineering, or a related field, with at least 7 years of relevant experience—or a Master’s/Ph.D. with 5+ years of experience.
- Deep expertise in biologics drug substance operations, both upstream and downstream.
- Effective communication skills and you are someone who keeps stakeholders informed and can explain complex technical topics clearly.
- The ability to thrive in dynamic environments and can manage ambiguity with flexibility.
- Strong leadership skills, able to motivate and guide diverse, cross-functional teams.
- Experience in regulatory requirements, cGMP, and lean manufacturing principles.
- Proficiency with digital tools like project management software, data visualization, and collaboration platforms.
- Excellent problem-solving skills and the ability to drive results through collaboration.
