Director / Senior Director, CMC – Process Chemistry

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

Location:

Headquarters: Palo Alto, CA, USA

Virtual-but-local model: candidates may work remotely but must be available for weekly in-person meetings at our Palo Alto headquarters.

Company Overview

We are a pre-clinical-stage biotechnology company focused on developing innovative therapies for patients with inflammatory or fibrotic diseases. We operate in a fast-paced, highly collaborative, and science-driven environment, and value entrepreneurial individuals who enjoy building processes, solving complex problems, and contributing hands‑on to the advancement of clinical programs.

About The Role

ALLIn Bio is advancing a small‑molecule pipeline, with our lead program entering Phase 1 and a second program moving toward IND‑enabling studies. We are hiring a Director/Senior Director, CMC – Process Chemistry to help the execution of CMC programs across our growing pipeline. You will be responsible of the CMC process chemistry programs, manage CDMO relationships, and ensure robust, scalable synthetic routes and control strategies as we advance programs from pre‑clinical to clinical, and from clinical development toward later‑stage and commercial manufacturing.

You will be the company's primary technical and day‑to‑day point of contact with our CDMO partners for process chemistry. You'll work closely with the current CMC lead, Quality, and Clinical Supply, and will have significant latitude to shape process chemistry strategy and CDMO partnerships as the company scales.

Key Responsibilities

• Serve as the primary, day‑to‑day technical point of contact with CDMO partners for process chemistry — technology transfer, process development, scale‑up campaigns, and GMP batch execution
• Own end‑to‑end process chemistry strategy for one or more small‑molecule drug substance programs, from route scouting/optimization through scale‑up and GMP manufacture, executed via CDMO partners
• Represent ALLInBio on‑site at CDMO facilities as needed for tech transfers, campaign readiness, and troubleshooting
• Develop and refine synthetic routes with attention to yield, cost of goods, impurity control, and scalability appropriate to each program's stage, in collaboration with CDMO process teams
• Contribute to solid form selection and crystallization development as needed to support drug substance specifications
• Author and/or review CMC sections of regulatory filings (IND, IMPD, briefing documents, and responses to health authority questions), and remain current on evolving Health Authority guidance and expectations
• Define and implement control strategies (critical process parameters, starting materials, specifications, impurity fate/purge) in collaboration with Analytical/CMC‑Analytical counterparts and CDMO analytical teams
• Review and approve technical development reports, batch records, campaign reports, change controls, CAPAs, deviations, and OOS/investigation responses coming from CDMOs
• Support Quality system documentation relevant to process chemistry — SOPs, batch release and disposition, Good Documentation Practices, and cGMP data traceability
• Manage process chemistry needs across multiple concurrent programs at different development stages, prioritizing CDMO engagement and timelines accordingly
• Contribute to CDMO selection, vendor qualification, and day‑to‑day contract/budget oversight for outsourced process development and manufacturing
• Partner cross‑functionally with Regulatory, Quality, Clinical Operations, Analytical Chemistry, and senior leadership on CMC risk assessment and program timelines

Candidate Profile

Required

• Ph.D. or M.S. in Organic Chemistry, Process Chemistry, or related field with a minimum of 10 years of relevant industry experience in small‑molecule drug substance development.
• Demonstrated track record advancing small‑molecule APIs from discovery/pre‑clinical through at least Phase 1, including hands‑on route design, process optimization, and scale‑up
• Direct, substantial experience managing CDMOs as the primary company‑side contact — technology transfer, process scale‑up, and GMP manufacturing oversight, including both dedicated FTE and fee‑for‑service engagement models
• Comfortable and effective operating as an individual contributor with high external visibility and accountability, without a supporting team
• Working knowledge of CMC regulatory requirements and experience contributing to IND/IMPD filings and health authority interactions; familiarity with ICH, FDA, and EMA guidelines
• Strong understanding of impurity control, quality‑by‑design (QbD) principles, phase‑appropriate control strategy/specification development, and process safety considerations for scale‑up
• Working knowledge of Quality systems — SOPs, batch record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, deviations, and change management
• Familiarity with analytical techniques supporting process development (e.g., UPLC/HPLC, GC, MS, NMR) and solid‑state characterization (e.g., XRPD, particle size distribution) sufficient to partner effectively with Analytical Chemistry
• Willingness and ability to travel domestically (and internationally, if applicable) to CDMO sites as needed
• Strong written and verbal communication skills

Preferred

• Experience managing process chemistry across multiple concurrent programs/modalities
• Prior experience in a small or growth‑stage biotech, operating without a large internal team
• Experience with salt/crystalline form selection and solid form development

Key Competencies

• Hands‑on, execution‑focused mindset
• Strong organizational and project management skills
• Excellent communication, presentation, and stakeholder‑management abilities
• Proactive problem‑solver who is comfortable operating in ambiguity
• Team‑oriented leader with a strong sense of ownership and accountability

Why Join Us

• Opportunity to make a direct and visible impact on development programs
• High level of responsibility and scientific influence in a growing startup
• Collaborative, rigorous, and science‑first culture
• Competitive compensation and benefits