Lead analytical development and control strategy for sterile injectable/parenteral products from development through commercialization.
Define analytical CMC strategies and regulatory submissions, including NDA Module 3 content and specifications.
Oversee stability programs, method lifecycle management, and external CDMO and contract laboratory execution.
Kailera is a biopharmaceutical company advancing novel therapies for obesity and related conditions. The company is an inclusive, team-oriented workplace with an entrepreneurial spirit focused on collaboration, integrity, and excellence.
Own CMC strategy and execution across the full portfolio, spanning drug substance, drug product, device/combination products, and oral solid dose formulations.
Lead process development, scale-up, technology transfer, and regulatory submissions for CMC and device sections to support global filings.
Build and mentor a high-performing CMC and device engineering organization while partnering cross-functionally with Regulatory, Quality, Clinical, and Commercial teams.
Kailera Therapeutics is a late clinical-stage biotechnology company advancing a pipeline of GLP-1-based therapies for obesity and related conditions, including injectable and oral candidates in global trials. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence as it scales toward commercial launch.
Serve as drug product technical leader for formulation, process development, scale-up, and technology transfer via external CDMOs.
Apply Quality by Design principles to define CQAs, CPPs, and robust control strategies for inhaled dry powder products.
Lead CMC submissions, regulatory interactions, and commercial readiness activities including PPQ and PAI support.
Pulmovant is a Roivant-backed clinical-stage biotechnology company focused on developing inhaled therapies for pulmonary diseases. It operates as a lean, collaborative team within the Roivant family, advancing a first-in-class candidate for PH-ILD through Phase 3 development.
Lead formulation and process development for inhaled dry powder products through scale-up and commercialization.
Apply Quality by Design principles and statistical tools to ensure product quality and regulatory compliance.
Collaborate with cross-functional teams and external CDMO partners to deliver CMC milestones and regulatory submissions.
Pulmovant is a biotechnology company developing inhaled dry powder therapies for serious pulmonary diseases. It is a lean, collaborative organization focused on bringing innovative treatments to patients with significant unmet medical needs.
Lead CMC workstream planning across multiple development programs, from technical development through regulatory submission.
Build integrated CMC timelines in Smartsheet and coordinate with CDMO partners on tech transfers and manufacturing.
Manage risks, budgets, and cross-functional technical operations teams to drive decisions and ensure on-time delivery.
Kailera is a biopharmaceutical company developing novel therapies for obesity and related conditions. It fosters an entrepreneurial, team-oriented culture and is committed to building an inclusive workplace.
Lead Kailera's end-to-end clinical and commercial supply chain, ensuring reliable delivery of investigational and commercial drug products.
Build and develop a high-performing global supply chain team, establishing governance, partnerships, and performance metrics.
Set global supply strategy and oversee logistics, compliance, systems, and budget to scale with company growth.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company fosters an entrepreneurial, team-oriented culture focused on collaboration, integrity, and excellence.
Own CMC end-to-end for a trispecific TCE program from discovery handoff to IND, including timeline, budget, and quality.
Run competitive CDMO selection across US, European and Chinese vendors, then negotiate and manage the chosen partner.
Author Module 3, build the pre-IND briefing package, and represent CMC in agency meetings.
Shennon Biotechnologies is developing precision immunotherapies for solid tumors using an integrated platform that profiles millions of single-cell interactions in a single experiment. The company values collaboration, ownership and authenticity and is based in San Francisco.