Develop and direct strategies for upstream and downstream process development, analytical development, and formulation development (including management of associated external CDMOs/CROs). * Author ...
Develop and direct strategies for upstream and downstream process development, analytical development, and formulation development (including management of associated external CDMOs/CROs). * Author ...
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Remote Director Formulation Development information
What does a Remote Director of Formulation Development do?
What are the key skills and qualifications needed to thrive as a Remote Director of Formulation Development, and why are they important?
What is the difference between Remote Director Formulation Development vs Remote Formulation Scientist?
| Aspect | Remote Director Formulation Development | Remote Formulation Scientist |
|---|---|---|
| Credentials | Advanced degrees (PhD, MS) in pharmaceutical sciences or related fields, extensive industry experience | Bachelor's or Master's in pharmaceutical sciences, chemistry, or related fields, with relevant experience |
| Work Environment | Leadership role overseeing teams, strategic planning, cross-department collaboration | Hands-on laboratory work, experimental design, data analysis |
| Employer & Industry Usage | Pharmaceutical and biotech companies, contract research organizations | Pharmaceutical companies, research labs, biotech firms |
The Remote Director Formulation Development typically holds a senior leadership position, focusing on strategic oversight and team management, while the Remote Formulation Scientist is more involved in experimental work and data generation. Both roles require relevant scientific credentials, but the director role emphasizes leadership and project management.
How does a Remote Director of Formulation Development typically collaborate with cross-functional teams given the virtual work environment?
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Full-time
Posted 13 days ago
Job description
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.
The role:
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.
Key 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.
Required experience & skills:
- 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
Base Salary Range: $300K - $375K
This role is eligible for a competitive total rewards package, including an annual bonus, equity, and a comprehensive benefits offering.
We are an equal opportunity employer.
We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires.
To learn more about E-Verify please review this poster.