Associate Director, CMC Team Lead
Core
Lead downstream process development for emerging modalities, focusing on antibody and antibody-oligonucleotide conjugate purification to enable transition from preclinical to Phase I clinical development.
Role type
Senior IC Associate Director, Downstream Process Development
Builds
Scalable, robust downstream purification processes for novel modalities
Domain
Biopharmaceuticals / Emerging Modalities / Downstream Processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Antibody purification, Antibody-oligonucleotide conjugate purification, Process development strategy, Scale-up, Regulatory CMC authorship, CDMO management, Analytical control strategy definition, Impurity clearance, UF/DF, Yield optimization
Preferred skills
Experience with non-platform molecules, Conjugation process alignment, Early clinical development planning
Technologies
None explicitly listed
Responsibilities
Lead downstream process development strategy for emerging modalities, Design and oversee phase-appropriate purification processes, Establish purification approaches for novel molecules, Partner with internal conjugation teams, Work with Analytical Development to define control strategies, Address purification challenges for complex molecules, Provide technical leadership for downstream activities at CDMOs, Collaborate with cross-functional teams for integrated CMC strategy, Author and review downstream sections of regulatory submission documents, Serve as downstream technical SME in regulatory discussions, Identify technical risks and scalability concerns, Build and standardize downstream development practices
Seniority
Senior, hands-on IC
