Director, DP Workstream Leader – Small Molecule Parenteral (LAIs and Oligos)
Core
Lead Drug Product (DP) workstream for sterile long-acting injectables (LAI) and oligonucleotide modalities, guiding cross-functional teams to design, develop, and transfer robust sterile formulations and processes.
Role type
Director, Drug Product Workstream Leader (Late-Phase)
Builds
Sterile formulations and processes for small molecule parenteral drugs and oligonucleotides
Domain
Biopharmaceuticals / Small Molecule Parenteral / Oligonucleotides
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cross-functional matrix leadership, late-stage project strategy execution, formulation and fill-finish process development, technology transfer to manufacturing/CMOs, regulatory submission support, risk and compliance management, strategic alignment of CMC objectives
Preferred skills
PhD in Chemical/Biochemical Engineering or Pharmaceutics, experience with successful filing and approval, deep knowledge of LAI and oligonucleotide development
Technologies
None explicitly listed
Responsibilities
Lead late stage development for New Chemical Entities from formulation to device design; Lead process development, scale-up, and technology transfer to manufacturing and CMOs; Oversee formulation and fill-finish process development ensuring stability and manufacturability; Coordinate clinical and commercial supply readiness; Shape and align CMC strategies with program objectives; Act as strategic interface between CMC project and function; Anticipate and mitigate risks across quality, supply, and compliance; Provide authoritative input to CMC regulatory submissions
Seniority
Director, strategic matrix leadership
