CMC Project Management Consultant

Job Description

We are seeking an experienced CMC Project Manager to oversee and drive cross-functional development programs for small molecule therapeutics. This role will provide leadership and coordination across CMC, non-clinical, clinical, and regulatory functions, ensuring that programs are executed on time, within budget, and in compliance with global regulatory standards. The ideal candidate possesses broad expertise in drug development, strong organizational skills, and the ability to influence and motivate diverse stakeholders to achieve program goals.

Roles and Responsibilities

• Oversee CMC timelines and deliverable completion for activities that include process development, manufacturing, analytical methods, formulation, stability, and clinical supply readiness across multiple suppliers to ensure that materials are delivered on time and within budget
• Develop and maintain integrated project plans covering scope, timelines, budgets, resources, and risk management strategies
• Track progress against milestones, anticipate issues, and implement corrective actions when necessary
• Provide clear, concise updates and presentations to executive leadership, governance committees, and external stakeholders
• Identify and mitigate program risks across technical, regulatory, operational, and financial dimensions.
• Partner with Regulatory Affairs to develop regulatory strategy toward NDA completion and submission
• Drive end-to-end program lifecycle ensuring stakeholder alignment and objective clarity

Qualifications - Requirements

• Advanced degree in life sciences, pharmaceutical sciences, or related field (PhD, PharmD, MS, or equivalent strongly preferred).
• 8 12+ years of experience in the pharmaceutical/biotech industry, with at least 5 years in program management.
• Proven track record managing small molecule development programs through clinical phases to NDA Submission.