Backed by GV.
About the role
The Director of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer, and quality control activities supporting a growing pipeline of small molecule Oral Solid Dose (OSD) and parenteral Drug Product programs. The incumbent will have deep experience in analytical activities required to support early-stage to late-stage oral solid dose and parenteral drug products.
What they're looking for
- 12+ years (Ph.D.)15+ years (MS) of progressive pharmaceutical or biotechnology analytical development experience
- Demonstrated deep experience in analytical development activities supporting Drug Product development and manufacturing with emphases on oral solid dose, parenteral, and pediatric formulations
- Proven track record advancing products from early development through late-stage clinical development and/or commercialization
- Demonstrated success working with CDMOs and global development partners
- Additional experience in development and implementation of analytical methods to support antibody/ADC manufacturing is preferred
More about this role
The Director of Analytical Development & Quality Control will provide strategic and operational leadership for analytical development, characterization, method validation, transfer, and quality control activities supporting a growing pipeline of small molecule Oral Solid Dose (OSD) and parenteral Drug Product programs. The incumbent will have deep experience in analytical activities required to support early-stage to late-stage oral solid dose and parenteral drug products. Additional experience in antibody/ADC manufacturing-focused analytical activities is desirable. This individual will be responsible for operating in a 100% outsourced environment to establish and manage phase-appropriate analytical strategies from preclinical through commercialization, overseeing external analytical operations, and ensuring compliance with global regulatory expectations and GMP requirements for assigned programs.
As a key member of the Technical Operations team, the Director will collaborate cross-functionally with Medicinal Chemistry, Toxicology, Clinical Pharmacology, Drug Substance, Drug Product, ADC production, Regulatory Affairs, Quality Assurance, and external CDMOs/CRO/consultants to...
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