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.
Lead analytical strategy and method lifecycle management for small molecule drug substance and drug product development.
Oversee external analytical partners, CDMOs, and testing laboratories to ensure cGMP compliance and quality.
Support regulatory submissions, specifications, stability programs, and commercialization readiness.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease and obstructive sleep apnea. The company is headquartered in Radnor, Pennsylvania and operates as a fully remote company.
Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.
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.
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 global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
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.
Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory submissions.
Provide hands-on CMC regulatory expertise across global filings, health authority interactions, and post-approval activities.
Collaborate with cross-functional teams to align regulatory strategy with scientific and compliance requirements.
The company is a biotechnology organization developing innovative cell therapies for late-stage and commercial stages. It offers a collaborative, entrepreneurial, and innovative work environment with a fast-paced, senior-level team.
Lead late-stage drug substance process design, optimization, and scale-up across global CDMOs.
Embed Quality by Design and DoE to define CPPs/CQAs and support regulatory submissions.
Drive tech transfer, PPQ campaigns, and cGMP compliance for commercial readiness.
Pulmovant is a Roivant-backed clinical-stage biotech developing inhaled therapies for pulmonary diseases. Its lead candidate, mosliciguat, is in Phase 3 for PH-ILD, and the company operates with a collaborative, fast-paced Roivant culture.