Director, CMC Process Chemistry – Scale-Up & Tech Transfer

BioSpace; Palo Alto (CA); Hybrid; USD 190,000 - 260,000; Full time

Job summary

ALLInBio in Palo Alto, CA is seeking a Director/Senior Director, CMC – Process Chemistry to lead end-to-end process chemistry programs, manage CDMO partnerships, and ensure scalable, compliant routes from pre-clinical to IND and into clinical development.

You will be the primary technical contact with CDMOs, shape CMC strategy, oversee regulatory filings (IND/IMPD), and collaborate with Quality, Regulatory, Clinical Operations, and senior leadership.

Qualifications

• Ph.D. or M.S. in Organic Chemistry, Process Chemistry, or related field with at least 10 years of industry experience.
• Hands-on route design, process optimization, and scale-up for small-molecule APIs through Phase 1.
• Extensive experience managing CDMOs as primary company contact for tech transfer and GMP manufacturing.
• Knowledge of CMC regulatory requirements and contribution to IND/IMPD filings.
• Strong communication and project management skills.

Responsibilities

• Serve as the primary day-to-day technical contact with CDMO partners for process chemistry.
• Own end-to-end process chemistry strategy across programs via CDMOs.
• Represent ALLInBio on-site at CDMO facilities for transfers and troubleshooting.
• Develop synthetic routes with focus on yield, cost of goods, impurity control, and scalability.
• Contribute to solid form selection and crystallization development.
• Prepare and review CMC sections of regulatory filings.
• Define and implement control strategies with Analytical/CMC teams.
• Review batch records, change controls, deviations, and OOS investigations.
• Support Quality system documentation (SOPs, batch release, data traceability).
• Manage process chemistry needs across concurrent programs and timelines.
• Contribute to CDMO selection, vendor qualification, and contract oversight.
• Collaborate with Regulatory, Quality, Clinical Operations, Analytical Chemistry, and leadership on CMC risk and timelines.

Skills

CDMO management

Process chemistry

IND/IMPD filings

Scale-up

Regulatory knowledge

Communication

Travel willingness

Education

Ph.D. in Organic Chemistry

M.S. in Organic Chemistry

Tools

UPLC/HPLC

GC

MS

NMR

XRPD

Job description

ALLInBio in Palo Alto, CA is seeking a Director/Senior Director, CMC – Process Chemistry to lead end-to-end process chemistry programs, manage CDMO partnerships, and ensure scalable, compliant routes from pre-clinical to IND and into clinical development.

You will be the primary technical contact with CDMOs, shape CMC strategy, oversee regulatory filings (IND/IMPD), and collaborate with Quality, Regulatory, Clinical Operations, and senior leadership.