CMC Senior Project Manager

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

About Tonix Pharmaceuticals

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first‑in‑class, once‑daily, non‑opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.

Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology, infectious disease, and rare disease. The CNS pipeline features small molecules and biologics to treat pain, neurological, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader‑Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA.

Tonix owns and operates a state‑of‑the‑art infectious disease research facility in Frederick, MD.

For more information, visit www.Tonixpharma.com.

About the Role

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.

Minimum Qualifications

• 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.

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).

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.

Skills

• Strong organizational and leadership skills to coordinate complex project activities and ensure timely delivery of milestones.
• Effective communication and stakeholder management across internal and external teams.
• Risk assessment, troubleshooting, and proactive corrective actions to keep projects on track.
• Proficiency in project management software for progress monitoring, resource allocation, and documentation.
• Alignment with regulatory frameworks to maintain compliance and support successful regulatory submissions.

Compensation & Benefits

• Annualized base salary ranging from $90,000 to $150,000 plus target incentive; actual salaries may vary based on experience, education, training, location, and merit.
• Medical, Dental & Vision insurance; basic and voluntary life and AD&D insurance; short‑ and long‑term disability insurance; flexible spending accounts; health savings account; and employee assistance programs.
• Pet insurance.
• Retirement savings 401k with company match and annual discretionary stock options.
• Generous paid time off, sick time, and paid holidays.
• Career development and training.

Recruitment & Staffing Agencies

Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.

Equal Employment Opportunity

Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leave of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, disability, veteran status, or any other characteristic protected by law.