Senior Manager, Project Management

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a private specialty pharmaceutical company committed to developing innovative medicines that address the needs of underserved patients. Renowned for delivering accessible, high-quality products, Azurity utilizes its integrated capabilities and extensive partner network to broaden its commercial offerings and strengthen its late-stage pipeline. Its patient-centric portfolio spans cardiovascular, neurology, endocrinology, gastrointestinal, institutional, and orphan drug markets, positively impacting millions worldwide.

Azurity fosters an inclusive work culture and is an Equal Opportunity Employer. Success arises from its talented and dedicated team focused on improving patient lives through scientific excellence and uncompromising quality.

Role Overview

This position requires an experienced Project Manager to lead multi-disciplinary pharmaceutical development programs, guiding projects from initial concept through to market launch. You will oversee planning, coordination, and monitoring of activities while ensuring cohesive collaboration between internal teams and external partners such as CMOs, CROs, and CDMOs. The role demands steering projects within timelines, budgets, and quality standards while proactively managing risks.

Key Duties

• Create and upkeep integrated project plans, including timelines, budgets, and resource allocations.
• Manage cross-functional team collaboration spanning R&D, Regulatory Affairs, Quality, Supply Chain, Commercial sectors, and external collaborators.
• Analyze project schedules critically to optimize and potentially shorten development timelines.
• Monitor progress, milestones, risks, dependencies, and outstanding tasks, ensuring issues are resolved promptly.
• Organize governance meetings and report project statuses to senior leadership regularly.
• Oversee technology transfer, product development, validation, regulatory registration, and launch activities.
• Coordinate with external service providers, including CMOs, CROs, and vendors, to fulfill project deliverables.
• Assist in budget preparation, forecasting, and controlling project expenditures.
• Ensure adherence to quality systems, regulatory guidelines, and company policies.
• Prepare detailed reports, presentations, risk evaluations, and executive summaries for various stakeholders.

Required Qualifications and Experience

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or closely related field.
• PMP certification and other relevant project planning credentials.
• At least 8 to 15 years’ experience in pharmaceutical product development, technical operations, or project management roles.
• Proven track record managing multiple complex pharmaceutical projects concurrently.
• Experience developing complex ANDA or NDA submissions for regulated markets.
• Strong expertise in project planning, scheduling, and risk mitigation strategies.
• Comprehensive understanding of pharmaceutical development processes, regulatory pathways, technology transfer, validation, and commercialization.
• Excellent analytical, problem-solving, and decision-making skills.

Preferred Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or equivalent with PMP and related certifications.

Additional Information

Applicants must be mentally and physically fit to perform the role's responsibilities without limitations. Candidates with any disability or restriction should disclose these to HR beforehand.