Senior Scientist, Analytical Methods - Large Molecules

Valid8 Financial, Inc.; Redwood City (CA); On-site; USD 165,000 - 200,000; Full time

Benefits offered by this job

Stock options

Medical, dental, vision benefits

Annual bonus program

Job summary

Programmable Medicine in the San Francisco Bay Area seeks a scientific leader to direct analytical method development for complex large molecule therapeutics, including ADCs, polymers, and nanomedicine platforms.

You will collaborate with Chemistry, Translational, Process Development, Quality, Regulatory Affairs, Manufacturing, and external CROs/CMOs to establish robust analytical strategies that support product characterization, process understanding, product test and release, and regulatory

Qualifications

• PhD in Analytical Chemistry or related discipline with 10+ years in biotech/pharma.
• Experience supporting complex large molecule therapeutics (ADC, dendrimers, polymers, biologics).
• Extensive experience developing analytical methods from discovery through clinical development.
• Strong knowledge of analytical techniques: HPLC, SEC, LC-MS/MS, NMR, UV-Vis.
• Experience leading method transfers to GMP manufacturing and CDMO/CRO management.
• Knowledge of FDA, ICH, USP, EMA CMC regulatory requirements and IND/NDA support.
• Excellent project management and cross-functional teamwork.
• Experience supervising a small scientific team.
• Peer-reviewed publications as co-author or lead author in analytical methods.

Responsibilities

• Subject matter expert in analytical methods development for large molecule therapeutics.
• Performs analytical development and optimizes methods from preclinical to Phase 2.
• Creates and implements novel ideas to support analytical activities.
• Leads analytical technology transfers to GLP laboratories in support of GMP production.
• Writes analytical method development reports, SOPs, and regulatory submission sections.
• Supervises laboratory personnel, sets priorities, timelines, and ensures quality documentation.

Skills

Analytical method development

HPLC

LC-MS/MS

NMR

Regulatory submissions support

Project management

Team leadership

GMP/CDMO experience

Cross-functional collaboration

Biotech/pharma domain knowledge

Education

PhD in Analytical Chemistry or related

Tools

HPLC

SEC

LC-MS/MS

LC-MS

NMR spectroscopy

UV-Vis spectroscopy

Dynamic Light Scattering (DLS)

Zeta potential analysis

Multi-angle light scattering (MALS)

Job description

Programmable Medicine in the San Francisco Bay Area seeks a scientific leader to direct analytical method development for complex large molecule therapeutics, including ADCs, polymers, and nanomedicine platforms.

You will collaborate with Chemistry, Translational, Process Development, Quality, Regulatory Affairs, Manufacturing, and external CROs/CMOs to establish robust analytical strategies that support product characterization, process understanding, product test and release, and regulatory