Senior Process Sciences Leader, CMC & IND Readiness

Programmable Medicine; Redwood City (CA); On-site; USD 250,000 - 290,000; Full time

Benefits offered by this job

Premium health plans

401(k) plan

Flexible PTO

11 paid holidays

Job summary

Programmable Medicine is seeking a Sr. Director, Process Sciences to build and lead CMC capabilities across drug substance development, scale-up, analytics, and GLP/GMP readiness. The role spans bench-scale synthesis to large-scale transfer for clinical studies.

A PhD in chemical engineering with deep organic chemistry knowledge and hands-on GLP/cGMP experience is required. The ideal candidate will drive QbD, method development, and regulatory submissions, while guiding a high-performing team

Qualifications

• PhD in Chemical Engineering with 12+ years in pharma/biotech.
• Experience leading process development and scale-up of small-molecule drug substances.
• Deep expertise in analytical chemistry and method validation.
• Thorough knowledge of GLP and cGMP regulations and ICH guidelines.

Responsibilities

• Lead route scouting, process chemistry, and process engineering for small-molecule payloads.
• Define QbD attributes, risk assessments, and DoE to establish control strategies.
• Develop purification and drying strategies for small molecules and conjugates.
• Prepare CMC documentation and support FDA interactions.

Skills

Process development

Scale-up

Analytical chemistry

GLP & cGMP knowledge

Regulatory submissions

Leadership

Education

PhD in Chemical Engineering

Tools

HPLC/UPLC

LC-MS

NMR

GC

DoE

CDMO management

Job description

Programmable Medicine is seeking a Sr. Director, Process Sciences to build and lead CMC capabilities across drug substance development, scale-up, analytics, and GLP/GMP readiness. The role spans bench-scale synthesis to large-scale transfer for clinical studies.

A PhD in chemical engineering with deep organic chemistry knowledge and hands-on GLP/cGMP experience is required. The ideal candidate will drive QbD, method development, and regulatory submissions, while guiding a high-performing team