Head of Chemistry, Manufacturing & Controls (CMC)

Braveheart Bio•San Francisco, CA

1d•Onsite

About The Position

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease. Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation. 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. 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. 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.

Requirements

Ph.D. (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a closely related field; exceptionally strong master’s candidates will be considered
Fifteen-plus years’ experience in the pharmaceutical or biotech industry, with five-plus years’ demonstrated leadership in small molecule process development
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
Leadership experience in managing diverse project activities with contract CDMO facilities
Direct experience with successful registrations and commercial launch of novel assets
Hands-on experience leading commercial readiness activities, including PPQ, process and analytical method validation, pre-approval inspection (PAI) readiness, and qualification of commercial-scale supply for global launch
Experience with clinical supply management, process scale-up and technology transfer, cGMPs, and ICH guidelines, as well as the CMC content of global regulatory submissions
Experience with small molecule development programs, from early stage through commercial
Knowledge of cGMP regulations
Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results
Demonstrated communication, problem-solving, and negotiation/decision-making skills
Ability to think outside of the box and challenge the status quo
Natural entrepreneurial spirit with unrelenting dedication to delivering results
Desire to work in a fast-paced, innovative environment
Natural collaborator who enjoys working on a cross-functional team
Ability to travel 10-20%, domestic and/or international

Responsibilities

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.
Develop and direct strategies for upstream and downstream process development, analytical development, and formulation development (including management of associated external CDMOs/CROs).
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.
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.).
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.
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.
Oversee the development and maintenance of the budget for assigned program activities, including the preparation of cost estimates for new work.
Develop and/or provide technical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc.).
Play a leadership role in the creation, maintenance, improvement, and compliance with quality system.
Contribute to the generation and protection of company intellectual property.
Lead, develop, and mentor direct reports.
Demonstrate success in a dynamic, interactive, fast-paced, and entrepreneurial environment.