CMC Senior Project Manager

Role Summary

The CMC Senior Project Manager will lead and coordinate Chemistry, Manufacturing, and Controls (CMC) activities to ensure the successful development and regulatory approval of pharmaceutical products. This role is pivotal in managing cross-functional teams, timelines, and resources to deliver project milestones on schedule and within budget. The Project Manager will serve as the primary point of contact between internal teams and external partners, facilitating clear communication and alignment on project goals. They will oversee risk management, issue resolution, and compliance with regulatory requirements throughout the product lifecycle. Ultimately, the CMC Project Manager ensures that all CMC deliverables meet quality standards and support the overall strategic objectives of the organization.

Responsibilities

• Develop, implement, and maintain detailed project plans for CMC activities, including timelines, resource allocation, and budget management.
• Coordinate cross-functional teams including R&D, manufacturing, quality assurance, and regulatory affairs to ensure alignment and progress toward project goals.
• Monitor project progress, identify potential risks or delays, and implement mitigation strategies to keep projects on track.
• Serve as the primary liaison with external partners, contract manufacturers, and regulatory agencies to facilitate smooth project execution.
• Prepare and present regular project status reports to senior management and stakeholders, highlighting key achievements and challenges.
• Ensure compliance with all relevant regulatory guidelines and internal quality standards throughout the project lifecycle.
• Manage documentation and data related to CMC activities to support regulatory submissions and audits.

Qualifications

• Bachelor‚Äôs degree in chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• Minimum of 5 years of experience managing CMC projects within the pharmaceutical or biotechnology industry.
• Proven knowledge of regulatory requirements related to CMC, including FDA, EMA, and ICH guidelines.
• Strong project management experience with demonstrated ability to lead cross-functional teams.
• Excellent communication and organizational skills, with proficiency in project management tools.

Preferred Qualifications

• Advanced degree (MS or PhD) in a relevant scientific field.
• Project Management Professional (PMP) certification or equivalent.
• Experience working with global teams and managing international regulatory submissions.
• Familiarity with electronic document management systems and quality management software.
• Background in biologics or advanced therapy medicinal products (ATMPs).

Skills

• Responsible for coordinating complex project activities and ensuring timely delivery of milestones through strong organizational and leadership skills.
• Manage diverse teams and maintain clear, consistent communication with internal and external stakeholders.
• Assess project risks, troubleshoot issues, and implement proactive corrective actions to keep projects on track.
• Utilize project management software to monitor progress, allocate resources, and maintain accurate documentation.
• Ensure alignment with regulatory frameworks to maintain compliance and support successful regulatory submissions.