BBOT ยท 1 day ago
Senior Director, Technical Product Lead (CMC)
United States
Full-time
Remote
Director/Executive
$258K/yr - $290K/yr
12+ years expBBOT is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for cancer. The Senior Director, Technical Product Lead (CMC) will lead the CMC strategy for development programs, ensuring alignment with regulatory expectations and overseeing cross-functional teams to meet program goals.
Biotechnology
Responsibilities
Serve as the CMC representative on the cross-functional program team, accountable for CMC strategy, planning, and execution
Define and maintain a phase-appropriate CMC development plan that integrates process, analytical, and formulation strategies in alignment with clinical and regulatory milestones
Translate overall program objectives into actionable CMC development plans with clear deliverables, budgets, and timelines
Partner with the Head of CMC and functional leads to ensure alignment across programs and effective resource planning
Anticipate program risks, identify critical path activities, proactively developing contingency plans to ensure uninterrupted supply and regulatory compliance
Partner with functional leads of Process Chemistry, Analytical Development, and Formulation to ensure all technical workstreams are progressing according to plan, with clear deliverables and interdependencies
Lead regular cross-functional CMC team meetings to track activities, coordinate workstreams, review progress, identify risks, drive decision-making, and resolve technical or operational challenges
Ensure timely communication of progress, issues, and mitigation strategies to the program team, governance committees, and senior management
Collaborate closely with Regulatory Affairs and Quality to ensure CMC documentation supports filings and inspections
Provide scientific and technical guidance across process, analytical, and formulation disciplines, ensuring sound scientific rationale and regulatory compliance
Oversee external manufacturing and testing partner steering committees, ensuring quality, timelines, and cost targets are met
Identify and mitigate CMC risks and implement proactive contingency plans
Lead the CMC team for assigned programs, fostering strong collaboration, accountability, and transparent communication
Provide mentorship and guidance to CMC functional team members and project managers
Actively contribute to CMC organizational strategy and continuous improvement initiatives
Work with CMC Project Manager and functional leads to ensure appropriate resourcing and budget development by strategic assessment of milestones and corresponding resource requirements, while providing periodic review of forecasted expenditures. Communicate to assess and confirm appropriate allocation and use of resources
Work with the CMC Project Manager and team to build and review monthly program updates to the Program Development Team and Quarterly Review Board to ensure transparency of progress and guide essential program decisions
Qualification
Required
Advanced degree (Ph.D. or M.S.) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
12+ years of progressive CMC experience in the biopharmaceutical industry, with a strong record of leadership across multiple technical functions
Proven experience leading cross-functional CMC teams from early development through late stage or commercial readiness
Deep understanding of regulatory expectations (FDA, EMA, ICH) and global submission requirements
Demonstrated ability to manage complex projects, multiple stakeholders, and external partners
Excellent leadership, communication, and organizational skills with a proactive, solution-oriented mindset
Ability to work in a fast-paced, matrixed, and externalized environment
Successful participation in IND and NDA/BLA submissions
Experience in a lean, cross-functional biotech environment balancing strategic and hands-on responsibilities
Benefits
Annual bonus
Stock-based long-term incentives
Medical, dental, and vision benefits
Retirement
Wellness stipend
Flexible time off
Company
BBOT
BBOT (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies.
51-200 employees
H1B Sponsorship
BBOT has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase