Backed by GV.
About the role
As a key member of the Technical Operations team, this leader will collaborate cross-functionally with Medicinal Chemistry, Toxicology, Clinical Pharmacology, Drug Substance, Drug Product, , Regulatory Affairs, Quality Assurance, and external CDMOs/CROs/consultants to advance programs efficiently through development milestones while building scalable analytical and quality control capabilities for a rapidly growing organization. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 12+ years (Ph.D.)15+ years (MS) of progressive pharmaceutical or biotechnology analytical development experience
- Demonstrated success in developing and validating discriminating dissolution methods for 1+ OSD tablets
- 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 desirable
More about this role
The Head 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 Dose and parenteral Drug Product programs. The incumbent will have deep experience in analytical activities required to support early-stage to late-stage drug substance as well as 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 will 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, this leader will collaborate cross-functionally with Medicinal Chemistry, Toxicology, Clinical Pharmacology, Drug Substance, Drug Product, , Regulatory Affairs, Quality Assurance, and external CDMOs/CROs/consultants to...
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