CMC Senior Project Manager

Tonix Pharmaceutical • North Dartmouth, MA

80d • $100,000 - $170,000

About The Position

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.

Requirements

• Bachelor's 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.

Nice To Haves

• 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).

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.

Benefits

• Medical, Dental & Vision Insurance
• Basic and Voluntary Life and AD&D Insurance
• Short- and Long-Term Disability Insurance
• Flexible Spending Accounts
• Health Savings Account
• Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match and annual discretionary stock options
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Career Development and Training

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees