Associate Director, Process Chemistry & CMC

Septerna; San Francisco (CA); On-site; USD 200,000 - 220,000; Full time

Benefits offered by this job

Stock options

Annual target bonus

Benefits package

Job summary

Septerna seeks an Associate Director of Process Chemistry to lead drug substance development across small molecule programs in South San Francisco, CA. You will drive route evaluation, optimization, scale-up, and GMP production while coordinating with CDMOs and cross-functional teams to ensure timely delivery of quality drug substances.

The role demands deep expertise in organic synthesis, analytical characterization, and cGMP regulatory expectations, with travel up to 20% as needed.

Qualifications

• PhD/MS/BS with increasing responsibilities in small molecule drug substance development.
• Proven record delivering non-GLP to IND-enabling materials and GMP clinical supplies.
• Experience evaluating routes, scaling up, and setting control strategies.

Responsibilities

• Act as SME for Process Chemistry supporting drug substance development.
• Lead route scouting, process optimization, and scale-up activities.
• Define starting materials and impurity specifications in line with regulatory expectations.
• Oversee CDMOs for route development and GMP manufacture.
• Collaborate across QBD, DMPK, and Clinical teams to meet program targets.

Skills

Small molecule chemistry

Process development

Scale-up

Analytical techniques

Data integrity &Documentation

Education

PhD in organic chemistry

MS in organic chemistry

BS in chemistry

Tools

UPLC/HPLC

GC

MS

NMR

XRPD

Job description

Septerna seeks an Associate Director of Process Chemistry to lead drug substance development across small molecule programs in South San Francisco, CA. You will drive route evaluation, optimization, scale-up, and GMP production while coordinating with CDMOs and cross-functional teams to ensure timely delivery of quality drug substances.

The role demands deep expertise in organic synthesis, analytical characterization, and cGMP regulatory expectations, with travel up to 20% as needed.