Director / Senior Director, CMC - Process Chemistry

ALLInBio, Inc.; Palo Alto (CA); Ibrido; USD 180.000 - 280.000; Tempo pieno

Descrizione del lavoro

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,

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Process Chemistry

CDMO management

Scale-up

IND/IMPD filings

Regulatory knowledge

Project management

Cross-functional collaboration

Analytical techniques

Communication

Formazione

Ph.D. in Organic Chemistry or Process Chemistry

M.S. in Chemistry

Strumenti

UPLC/HPLC

GC

NMR

XRPD

GMP knowledge

Descrizione del lavoro

ALLInBio

Location:

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
• 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