Cell & Gene Therapy SME (US)

Location: United States. Remote work is supported; employees within a reasonably short commute of an office are encouraged to work on a hybrid basis as agreed with their manager. Willingness to travel is required.

Company

hirify.global provides consulting and expertise across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Deliver Cell and Gene Therapy projects covering product development, analytical method development and transfer, facility startup and qualification, and process improvement.
• Plan and manage project scope, schedules, resources, quality, risks, issues, budgets, and client billings.
• Lead project meetings, workshops, stakeholder communications, decision-making, status reporting, dashboards, and client approvals.
• Prepare project plans, charters, communication plans, presentations, budgets, and other project deliverables.
• Support business development, sales materials, client proposals, staffing, recruiting, and industry presentations related to CGT.
• Supervise personnel and support goal setting, performance evaluations, training, development, and adherence to company policies.

Requirements

• 10 or more years of multidisciplinary experience in the CGT pharmaceutical and biotech industries.
• At least 10 years of direct CGT project management experience.
• Bachelor’s degree in Life Sciences or a related field; an advanced scientific degree is preferred. Ten years of relevant experience may substitute for education.
• Knowledge of the drug development process, Good Manufacturing Practices, and ISO requirements relevant to CGT operations.
• Experience with complex project timelines and resources using MS Project or comparable project management software.
• Excellent written and spoken English, strong analytical and presentation skills, stakeholder management ability, independent work capability, and willingness to travel.

Nice to have

• Advanced degree in a scientific discipline.
• Experience supporting sales activities for project services.
• Supervisory experience including hiring, retention, performance reviews, employee development, and discipline.
• Additional language skills.

Culture & Benefits

• Remote work is supported, with hybrid collaboration encouraged for employees near an office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Environment that encourages innovation, collaboration, entrepreneurship, and authentic participation.
• Applications are reviewed personally by the recruitment team rather than AI screening tools.