Senior Manager, Drug Substance Manufacturing Upstream (Gene Therapy)

Location: Bedford, MA; the majority of work must be conducted on-site. The role supervises a rotating 12-hour shift from 7 a.m. to 7 p.m., with every other weekend off, and requires on-call availability for upstream manufacturing alarms outside scheduled shifts.

Salary: $159,500–$197,100 USD annually, with eligibility for an annual bonus and equity incentives.

Company

hirify.global develops medicines for rare diseases, including gene therapy products, with a focus on innovative treatments and patient impact.

What you will do

• Supervise five manufacturing technicians and Associates, overseeing compliance, training, safety, and career development.
• Lead cell culture operations from vial thaw through 2K operations for viral particle production.
• Act as area lead for internal and external audits, host tours, and serve as a front-room subject matter expert during regulatory inspections.
• Drive completed batch record review according to the release plan and manage deviations, CAPA, change controls, SOPs, MBRs, and risk assessments.
• Ensure materials, personnel, documentation, equipment, and facility resources are ready for processing and maintain business system ownership.
• Lead continuous improvement and cross-functional projects through completion in a matrix environment.

Requirements

• Degree in engineering or a scientific discipline; equivalent education and experience may be considered.
• 10+ years in leadership positions with direct reports, ideally in a 24/7 biologics environment.
• Experience with GMP manufacturing of viral vectors and/or biological processes.
• Strong collaboration, teamwork, and communication skills.
• Ability to work primarily on-site, follow a rotating 12-hour schedule, and be on call for upstream manufacturing alarms off shift.
• Ability to stand for extended periods and periodically stoop, bend, or kneel; lift, push, and pull up to 50 lb; and climb ladders and stairs.
• Ability to work in controlled, temperature-controlled environments using GxP gowning and protective equipment, including removing makeup, jewelry, and contact lenses.
• Ability to use a respirator when required; advance medical clearance may be required.

Culture & Benefits

• Supportive and inclusive environment focused on learning, growth, and meaningful patient impact.
• Vacation time, company-observed public holidays, and volunteer days.
• Long-term incentive and employee stock purchase plans or equivalent offerings.
• Employee wellbeing benefits and fitness reimbursement.
• Tuition sponsorship and professional development plans.
• Benefits vary by region and country.