CMC Dossier Leader (AI)

Location: Hybrid role based in Framingham, Massachusetts, United States; available to US and Puerto Rico residents only.

Salary range: $148,500–$214,500 per year.

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunoscience, AI, data, and digital platforms.

What you will do

• Lead and coordinate CMC dossier preparation and development for clinical and market authorization submissions.
• Align dossier strategy with CMC activities and ensure data supports progression to clinical development and patients.
• Lead dossier subteams and submission taskforces through authoring, review, comment resolution, and approval.
• Ensure consistent information across CMC dossiers and related clinical and preclinical modules.
• Improve submission templates and authoring guides with CMC, regulatory, and digital functions.
• Assess CMC dossier content for M&A and in-licensing due diligence and drive AI-powered document solutions.

Requirements

• PhD, MS, or another university degree in pharmaceutical chemistry, pharmacy, biochemistry, or a related pharmaceutical drug development field.
• At least 5 years of professional experience in CMC development and a proven record of authoring CMC dossiers.
• Deep knowledge of pharmaceutical development and CMC development for synthetic products, including chemistry, drug product development, analytical development, or process and method validation.
• Knowledge of CMC dossier structures and regulatory documents for clinical trials, market authorization, agency consultations, inspections, and information requests.
• Ability to lead cross-functional teams and collaborate with internal and external partners.
• Proficiency in Vault RIM, Microsoft Word, and Adobe; readiness to adopt AI, ML, and other digital technologies.

Nice to have

• Experience with agile or Scrum methodologies in pharmaceutical development.
• Experience with data integration platforms.
• Knowledge of digital quality management systems and electronic batch records.

Culture & Benefits

• Supportive, future-focused environment centered on science, innovation, and patient impact.
• Career development opportunities through promotion or lateral moves, including international opportunities.
• Healthcare, prevention, wellness, and other employee benefits.
• At least 14 weeks of gender-neutral parental leave.
• Work with AI, data, and digital platforms at the forefront of drug discovery and development.