Director, Process Chemistry — Small‑Molecule API Leader

ALLInBio, Inc.; Palo Alto (CA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

ALLInBio, Inc. is seeking a Director/Senior Director, CMC – Process Chemistry to lead process chemistry programs across our small‑molecule pipeline.

You will be the primary technical contact with CDMOs, shape strategy, and ensure scalable routes and robust control strategies as programs progress from pre‑clinical to clinical and toward late‑stage development. You’ll collaborate with Regulatory, Quality, and Clinical Supply, and have substantial latitude to influence CDMO partnerships,

Qualifications

• Ph.D. or M.S. in Organic or Process Chemistry with 10+ years in small‑molecule API development.
• Hands‑on route design, process optimization, and scale‑up experience to early clinical stages.
• Direct CDMO management as primary company contact for transfers and GMP manufacturing.
• Familiar with CMC regulatory requirements and health authority interactions (IND/IMPD).
• Strong written and verbal communication; cross‑functional collaboration with Regulatory and QA.

Responsibilities

• Serve as the day‑to‑day technical contact with CDMOs for process chemistry and GMP batches.
• Own end‑to‑end process chemistry strategy for one or more programs via CDMOs.
• Represent ALLInBio on‑site at CDMO facilities for tech transfers and troubleshooting.
• Develop routes with focus on yield, cost of goods, impurity control, and scalability.
• Contribute to solid form selection and crystallization development as needed.
• Prepare/review CMC sections of filings; stay current with regulatory guidance.
• Define control strategies with Analytical/CMC teams and CDMO analytics.
• Review batch records, change controls, CAPAs, deviations, and OOS investigations.
• Support Quality system documentation: SOPs, batch release, and data traceability.
• Manage needs across programs and prioritize CDMO engagement and timelines.
• Contribute to CDMO selection, vendor qualification, and budget oversight.
• Collaborate with Regulatory, Quality, Clinical Ops on risk assessment and timelines.

Skills

Process Chemistry

CDMO management

Scale-up

IND/IMPD filings

Regulatory knowledge

Project management

Cross-functional collaboration

Analytical techniques

Communication

Education

Ph.D. in Organic Chemistry or Process Chemistry

M.S. in Chemistry

Tools

UPLC/HPLC

GC

NMR

XRPD

GMP knowledge

Job description

ALLInBio, Inc. is seeking a Director/Senior Director, CMC – Process Chemistry to lead process chemistry programs across our small‑molecule pipeline.

You will be the primary technical contact with CDMOs, shape strategy, and ensure scalable routes and robust control strategies as programs progress from pre‑clinical to clinical and toward late‑stage development. You’ll collaborate with Regulatory, Quality, and Clinical Supply, and have substantial latitude to influence CDMO partnerships,