Director, Drug Product (Biopharmaceutical)

Location: Remote within any US state; domestic travel and occasional vendor site visits may be required.

Salary: $215,000–$235,000 per year, plus performance-based bonus and equity.

Company

hirify.global is a biopharmaceutical company developing novel therapeutic candidates for oncology and addressing unmet medical needs.

What you will do

• Lead drug product development from preclinical research through clinical phases, regulatory submission, commercialization, and lifecycle management.
• Direct pre-formulation, formulation, dosage-form selection, process development, scale-up, validation, and GMP manufacturing activities.
• Translate preclinical pharmacology, toxicology, and PK findings into clinical dosage forms such as capsules, tablets, and injectables.
• Select and manage contract research and manufacturing organizations, including vendor deliverables, budgets, timelines, investigations, deviations, and batch documentation.
• Develop CMC development strategies, technical reports, SOPs, policies, and drug product sections for regulatory submissions.
• Coordinate with Preclinical, Clinical, Analytical, CMC, Quality, Regulatory, Project Management, consultants, and external partners.

Requirements

• MS or PhD in Pharmaceutical Sciences, Chemical Engineering, or a closely related field preferred; equivalent education and experience may be considered.
• 8+ years of relevant experience in the pharmaceutical or biotechnology industry, with experience spanning preclinical through later-stage development.
• Comprehensive knowledge of CMC functions, drug substance and drug product development, analytical methods, quality, and regulatory requirements.
• Strong understanding of GMP practices, cGMP regulations, USP, EP, JP, and related guidance documents.
• Experience with traditional and complex dosage forms, contract development and manufacturing organizations, and clinical manufacturing operations.
• Demonstrated leadership, vendor management, problem-solving, communication, and cross-functional collaboration skills.

Nice to have

• Background in contract pharmaceutical development and manufacturing.
• Experience supporting regulatory submissions, product registration, commercial readiness, and post-approval commitments.

Culture & Benefits

• Virtual remote work environment with domestic travel as needed.
• Unlimited vacation and 10 sick days annually.
• Medical, dental, and vision coverage.
• 401(k) with company matching.
• Performance-based bonus and long-term incentive equity plans.