Own CMC oversight across every active asset, ensuring on-time and on-budget delivery of drug substance, drug product, analytics, stability, and regulatory filings.
Select, contract, and manage CDMOs and external partners, holding them to timelines, quality, and cost.
Scope and de-risk the CMC of inherited in-licensing candidates, flagging manufacturing complexity or cost that could affect asset viability.
Our mission is to fix the broken clinical-stage biopharma model by in-licensing therapeutic assets and developing them through integrated, technology-first clinical trial infrastructure. We are a new initiative built on a proven foundation, with a team that has delivered 40+ trials across the US and Europe, and we are a high-growth, mission-driven, VC-funded startup.
Serve as a trusted CMC advisor to clients, providing strategic guidance across all phases of product development.
Lead and manage CMC development activities for drug substances and drug products, ensuring alignment with program objectives and regulatory requirements.
Oversee CDMO/CMO selection, qualification, contracting, and ongoing management.
We accelerate breakthrough science and delivery of life-enhancing therapies through our expertise, insight, consulting and management skills. We were recently honored with BioSpace's 'Best Places to Work' 2026 award, fostering a positive and engaging work environment with emphasis on culture, career growth, and development.
Lead CMC regulatory strategy for small molecule drugs in global Phase 1-3 trials.
Write and manage investigational regulatory submissions for US, EU, and ROW.
Support risk mitigation and GMP compliance across development programs.
Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. The company employs a global team and fosters a culture of bold action, care, and collaboration.
Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.
Lead CMC regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA submissions.
Prepare and review CMC regulatory documents, assess changes, and collaborate cross-functionally to ensure compliance.
Represent regulatory on study teams and maintain knowledge of US and international regulations.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. The company targets the RAS/MAPK pathway and fosters a collaborative, mission-driven culture.
Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.
Serve as subject matter expert defining gold standard for regulatory content on an AI platform.
Ensure outputs reflect current agency expectations and are ready for global submission.
Work flexibly 5–20 hours per week in a remote, US-based role.
Edison Scientific builds and commercializes AI agents for science. They are assembling a team of top researchers and engineers across AI and biology with a fast-moving, mission-driven culture.
Lead and personally execute biologics CMC consulting engagements as the primary technical point of contact across program lifecycle.
Establish and grow Syner-G's presence in the West Coast biologics market, focusing on Bay Area, San Diego, and Seattle biotech corridors.
Provide expert guidance across biologics development including upstream and downstream process development, analytical characterization, and CMC regulatory strategy.
Syner-G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and delivery of life-enhancing therapies. The company has been honored with BioSpace's prestigious 'Best Places to Work' award for three consecutive years, fostering a culture focused on career growth, development opportunities, and financial rewards.
Lead project initiation, planning, and execution for API and drug product development projects.
Serve as liaison between clients, technical teams, and business development to ensure project success.
Monitor project progress, report to stakeholders, and implement corrective measures using risk assessment tools.
WuXi, through its STA division, provides API and drug product development and manufacturing services. The company is a leading global contract research and manufacturing organization with a focus on small molecule development.