CMC Project Manager – Biotech Regulatory & Delivery

Tonix Pharmaceuticals; North Dartmouth (MA); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental & Vision insurance

401k with company match

Generous paid time off

Job summary

A biotechnology company in North Dartmouth is seeking a CMC Senior Project Manager. The role involves leading Chemistry, Manufacturing, and Controls activities to ensure successful project milestones. Candidates should possess a Bachelor's degree in a relevant field and a minimum of 5 years of CMC project management experience in the pharmaceutical or biotechnology industry. Excellent communication and organizational skills are essential. This position offers a competitive salary between $90,000 and $150,000 plus benefits.

Qualifications

• 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.

Responsibilities

• Develop, implement, and maintain detailed project plans for CMC activities.
• Coordinate cross-functional teams including R&D, manufacturing, and regulatory affairs.
• Monitor project progress, identify risks or delays, and implement mitigation strategies.

Skills

Project management

Communication skills

Organizational skills

Risk management

Education

Bachelor’s degree in chemistry, pharmaceutical sciences, engineering, or a related scientific discipline

Tools

Project management tools

Job description

A biotechnology company in North Dartmouth is seeking a CMC Senior Project Manager. The role involves leading Chemistry, Manufacturing, and Controls activities to ensure successful project milestones. Candidates should possess a Bachelor's degree in a relevant field and a minimum of 5 years of CMC project management experience in the pharmaceutical or biotechnology industry. Excellent communication and organizational skills are essential. This position offers a competitive salary between $90,000 and $150,000 plus benefits.