Head of Chemistry, Manufacturing & Controls (CMC)

About this role

<div class="content-intro"><p><strong>About us:</strong></p> <div> <p class="x_MsoNormal"><span data-olk-copy-source="MessageBody">Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.</span></p> </div> <div> <p class="x_MsoNormal">With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.</p> </div> <p> </p></div><p><strong>The role:</strong></p> <p>As Braveheart Bio advances its lead small molecule program toward late-stage development, the Head of CMC will serve as a key technical and operational leader, responsible for all Chemistry, Manufacturing, and Controls (CMC) activities across development and supply.</p> <p>Reporting to the executive team, this individual will lead drug substance and drug product process development, manufacturing strategy, and external supply chain execution, while partnering closely with internal cross-functional teams and a network of global CDMOs and CROs. The Head of CMC will play a critical role in ensuring regulatory readiness, technical excellence, and scalable, compliant manufacturing to support clinical development and eventual commercialization. A central focus of the role will be driving commercial readiness and supporting a successful global launch, including process validation, scale-up to commercial volumes, qualification of a robust commercial supply network, and delivery of the launch CMC package to support NDA/MAA approval and market entry.</p> <p> </p> <p><strong>Key responsibilities:</strong></p> <ul> <li>Direct all aspects (DS/DP) of process development and supply chain operational activities for the company’s programs; work closely with external CROs/CDMOs, collaborators, and/or partners to rapidly advance programs to key decision points.</li> <li>Develop and direct strategies for upstream and downstream process development, analytical development, and formulation development (including management of associated external CDMOs/CROs).</li> <li>Author and review technical sections for company’s global regulatory submissions (INDs, CTAs, IMPDs, NDAs, MAAs, meeting requests, briefing documents, responses to health authority questions, etc.) related to assigned programs.</li> <li>Collaborate with team members to efficiently evaluate, select, and manage contract service providers (CDMOs and CROs), including technology transfer, process scale-up, design of validation strategies, packaging development, and technical expertise with regards to routine/non-routine development and cGMP activities (e.g., deviations/investigations, process improvements, change controls, CAPAs, etc.).</li> <li>Lead end-to-end commercial CMC readiness, including process performance qualification (PPQ), process validation, analytical method validation, and stability programs required to support NDA/MAA filings and global launch.</li> <li>Build and qualify the commercial supply network, including launch and post-launch demand planning, inspection readiness for pre-approval inspections (PAI), serialization and packaging strategy, and partnership with Commercial, Quality, and Regulatory to ensure on-time product availability across launch markets.</li> <li>Oversee the development and maintenance of the budget for assigned program activities, including the preparation of cost estimates for new work.</li> <li>Develop and/or provide technical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc.).</li> <li>Play a leadership role in the creation, maintenance, improvement, and compliance with quality system.</li> <li>Contribute to the generation and protection of company intellectual property.</li> <li>Lead, develop, and mentor direct reports.</li> <li>Demonstrate success in a dynamic, interactive, fast-paced, and entrepreneurial environment.</li> </ul> <p> </p> <p><strong>Required experience & skills:</strong></p> <ul> <li>Ph.D. (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a closely related field; exceptionally strong master’s candidates will be considered</li> <li>Fifteen-plus years’ experience in the pharmaceutical or biotech industry, with five-plus years’ demonstrated leadership in small molecule process development</li> <li>Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage small molecule assets, including upstream/downstream process development, formulation development, analytical development, and device development</li> <li>Leadership experience in managing diverse project activities with contract CDMO facilities</li> <li>Direct experience with successful registrations and commercial launch of novel assets</li> <li>Hands-on experience leading commercial…