Principal Scientist, Regulatory CMC

Location: On-site in Summit, New Jersey, United States; Monday–Friday during standard business hours, with flexibility subject to manager approval.

Salary: $170,000–$187,000 annual base pay, plus discretionary bonus and equity award.

Company

hirify.global is a commercial-stage biotechnology company developing cell and immunotherapy products, vaccines, and other therapies for cancer and infectious diseases.

What you will do

• Develop global Chemistry, Manufacturing and Control regulatory strategies for investigational and marketed products.
• Prepare and review CTD Module 2 Quality Overall Summaries and Module 3 documents in eCTD format.
• Generate submission-ready Quality/CMC content for clinical trial and marketing authorization applications.
• Review pharmacy manuals, protocols, CMC reports, and related regulatory documentation.
• Provide expert opinions on CMC topics, contribute to CMC protocol design, and address cross-functional CMC matters.
• Prepare responses to Health Authority questions and train colleagues on Regulatory Affairs SOPs, processes, templates, and document quality control.

Requirements

• Bachelor’s degree in life sciences or a technical discipline with 10+ years of relevant progressive experience, or a master’s degree with 8+ years, or a doctorate with 6+ years.
• Experience preparing CMC module submissions in eCTD format.
• Familiarity with organizing responses to Health Authority requests.
• Knowledge of Health Authority procedures, electronic submissions, document management, and CMC guidance requirements.
• Proficiency with Electronic Document Management Systems and strong organizational, communication, and detail-oriented skills.
• Ability to work on-site in Summit, NJ and meet standard Monday–Friday business hours.

Nice to have

• Experience with regulatory submissions outside the United States.
• Knowledge of biologic-based drugs, including cell-based therapies, gene therapies, antibodies, and recombinant proteins.

Culture & Benefits

• Collaborative work across scientific and cross-functional project teams.
• Professional development opportunities in a growing publicly traded biopharmaceutical company.
• Medical, dental, and vision plan options, along with health and financial wellness programs.
• 401(k) retirement plan with company match, flexible spending accounts, life and disability insurance, and an employee assistance program.
• Paid time off, holidays, education savings support, legal services, identity theft protection, pet insurance, and employee discounts.