The Senior Scientist, Drug Product/Parenteral Expert serves as the technical subject matter expert for drug product and parenteral development across pipeline and commercial products within Eye Care and Novel Therapies. This role provides scientific leadership in process development, manufacturing support, tech transfer, scale-up, and lifecycle management of sterile and parenteral product. The candidate will partners cross-functionally with Research, Development, Manufacturing, Quality, Regulatory, Supply Chain, and external partners to ensure robust product development and reliable commercial supply.

Key Responsibilities

• Act as the Drug Product lead for pipeline and marketed products.
• Lead or support process development for eye care and gene therapy products, including solution, suspension, lyophilized, and other injectable dosage forms.
• Drive development of drug product strategies aligned with target product profiles, quality attributes, and clinical/commercial requirements.
• Provide technical oversight for process development, process characterization, scale-up, validation, and tech transfer activities.
• Support manufacturing issue resolution, deviation investigations, root cause analysis, and implementation of corrective and preventive actions.
• Partner with internal and external manufacturing sites, CMOs, and vendors to ensure product robustness and supply reliability.
• Contribute to CMC documentation for regulatory submissions, technical reports, responses to agency questions, and lifecycle changes.
• Evaluate and implement innovative drug product solutions for novel therapies.
• Assess product stability, compatibility, container closure systems, and storage/shipping considerations.
• Collaborate with Quality, Regulatory, Analytical, and Clinical teams to ensure alignment on development strategy and execution.
• Mentor junior scientists and contribute to scientific capability building within the organization.
• Represent drug product expertise in cross-functional governance forums and project teams.