Lead operational and lifecycle management of Regulatory CMC submissions for cell therapy programs.
Develop and execute global regulatory CMC strategies aligning with program objectives.
Serve as Regulatory CMC lead on cross-functional teams, providing strategic guidance.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. It operates as a small, mission-driven company in a fast-paced environment.
Provide quality oversight and direction to vendors to ensure cGMP compliance for clinical manufacturing.
Lead clinical lot disposition, batch record review, and QP certification for global trials.
Oversee GMP quality systems including deviations, investigations, and audits at contract manufacturing partners.
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. It is a small, lean organization within the Roivant family, focusing on collaboration and innovation.
Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, packaging, and labeling.
Lead resolution of deviations, OOS/OOT, change controls, CAPAs, and product quality complaints with risk-based decisions.
Represent Product Quality on CMC and external partner teams to support development, regulatory submissions, and commercialization.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company values trust, ownership, curiosity, and results, fostering a culture of diversity and inclusion with a small but dedicated team.
Develop and implement global CMC regulatory strategies for biologic and combination products.
Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
Serve as the CMC Regulatory lead on cross-functional project teams and support health authority interactions.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.
Manage and oversee the GCP Quality Management System for global clinical operations, including decentralized trials.
Lead quality investigations, CAPAs, and audits to ensure compliance with regulatory standards.
Provide strategic quality advice and drive continuous improvement across the organization.
WEP Clinical partners with biopharmaceutical sponsors to bring treatments to patients through clinical trial delivery and home health services. With over 15 years of global experience, the company fosters a collaborative, innovative culture focused on improving patient outcomes.
Own GTI's QA/QC policies, SOPs, and quality management system across a multi-state network, driving consistency and continuous improvement.
Direct company-wide sanitation and QC practices ensuring product purity, consistency, and compliance with regulatory standards.
Manage nonconformance records, CAPA processes, and complaint investigations to drive systemic improvements and regulatory compliance.
Green Thumb Industries is a multi-state cannabis operator involved in cultivation, manufacturing, and production of cannabis products. The company emphasizes a culture of quality, food-safety, and compliance excellence across its network.
Provide strategic pharmaceutical development guidance as CMC lead to cross-functional project teams.
Develop robust formulations and manufacturing processes to support rapid registration of QED products.
Manage CRO relationships, drug forecasts, and regulatory submissions for clinical supply.
BridgeBio is a biotech company pioneering a 'moneyball for biotech' approach to reduce risk and accelerate development of life-changing medicines for rare diseases. They foster a culture of curiosity and experimentation, working alongside respected industry minds to reengineer the future of biopharma.
Support GMP CMC operations including review of batch records, analytical data, and product release for clinical-use drug substances and products.
Manage quality oversight for GMP vendors, audits, and quality agreements, and act as a QA point of contact for internal and external partners.
Review and approve quality events such as OOS, deviations, CAPAs, and change controls to ensure regulatory compliance.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for patients with cancer, targeting the RAS/MAPK pathway. With a small, collaborative team and a casual, mission-driven culture, they are committed to erasing cancer.
Develop and execute a global training strategy tailored to cell therapy programs across clinical and commercial stages.
Build role-specific onboarding, certification, and continuous learning pathways for Medical and Commercial field teams.
Deliver comprehensive training including disease state education, CAR T product design, clinical data, safety monitoring, and competitive landscape.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. It is a scaling biotech environment with a culture driven by core values of collaboration, clarity, innovation, and ownership.
You will lead global regulatory strategy for drug development programs, focusing on Ex-US health authorities.
You will manage and create high-quality regulatory submissions, including Clinical Trial Applications and Market Applications.
You will collaborate cross-functionally to negotiate optimal development paths and ensure compliance with evolving regulations.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.
Manage analytical development, QC, and stability activities at contract manufacturing sites.
Author and review CMC sections for US and ex-US regulatory filings.
Collaborate with Quality Assurance to close investigations and manage change controls.
BridgeBio is a biotech company that pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and develop medicines for rare diseases. They foster a culture of curiosity and experimentation with small teams of experts.
Lead and develop a world-class Service & Repair Quality organization across multiple international sites, driving continuous improvement and regulatory compliance.
Apply global regulatory requirements to Service & Repair processes, including FDA, GMP, CAPA, ISO 13485, and lead quality support during regulatory inspections.
Develop statistically sound sampling plans, use data analysis to identify trends, and build strong partnerships with site leadership and stakeholders.
This is a senior quality leadership opportunity within a global medical technology environment focused on delivering safe, reliable, and innovative healthcare solutions. The company is a partner of Jobgether, with operations across the US, Germany, and Japan, and emphasizes a collaborative, ethical, and inclusive culture.
Develop and execute a comprehensive global training strategy for cell therapy programs across clinical and commercial stages.
Build role-specific onboarding, certification, and continuous learning pathways for Medical, Commercial, and other teams.
Ensure training content complies with FDA, EMA, and global regulatory requirements while measuring competency and launch preparedness.
The company is a clinical-stage biotechnology organization developing innovative advanced therapies. It operates in a fast-paced, collaborative environment with a focus on launch readiness and cross-functional teamwork.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.