ELKA Search Partners
Vice President, Drug Product
ELKA Search Partners, San Francisco, California, United States, 94199
We are seeking an experienced Drug Product leader to oversee formulation development, process scale-up, technology transfer, commercial manufacturing, and global supply continuity. This role will partner closely with Technical Operations, Quality, Regulatory, CMC, and Commercial to ensure robust and compliant support for clinical and commercial programs.
Key Responsibilities
Lead all drug-product development and manufacturing activities from late-stage development through commercialization.
Provide technical oversight for formulation, process design, scale-up, validation, and commercial readiness.
Manage CMO/CDMO partnerships and ensure reliable, compliant, and cost-effective supply.
Oversee technology transfer, commercial manufacturing, and continuous improvement of solid oral dosage forms.
Support regulatory submissions and inspections by contributing to CMC strategy and documentation.
Qualifications
Master’s degree or Ph.D. in a relevant scientific discipline.
20+ years of experience overseeing small-molecule CMC from preclinical through commercialization.
Strong background in outsourced drug-product development, including solid oral dosage and modified-release formulations.
Proven success managing CMO/CDMO relationships and cross-functional technical operations.
Strong technical judgment, communication skills, and ability to lead in a fast-paced environment.
Seniority level
Executive
Employment type
Full-time
Job function
Research
Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr
Key Responsibilities
Lead all drug-product development and manufacturing activities from late-stage development through commercialization.
Provide technical oversight for formulation, process design, scale-up, validation, and commercial readiness.
Manage CMO/CDMO partnerships and ensure reliable, compliant, and cost-effective supply.
Oversee technology transfer, commercial manufacturing, and continuous improvement of solid oral dosage forms.
Support regulatory submissions and inspections by contributing to CMC strategy and documentation.
Qualifications
Master’s degree or Ph.D. in a relevant scientific discipline.
20+ years of experience overseeing small-molecule CMC from preclinical through commercialization.
Strong background in outsourced drug-product development, including solid oral dosage and modified-release formulations.
Proven success managing CMO/CDMO relationships and cross-functional technical operations.
Strong technical judgment, communication skills, and ability to lead in a fast-paced environment.
Seniority level
Executive
Employment type
Full-time
Job function
Research
Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr