CMC Lead, SME (Biologics)

Location: Remote from the United States or European Union; client visits, conferences, and trade shows may be required.

Company

hirify.global is a biotechnology and life-science services company, with ProBio providing end-to-end CDMO services for plasmids, antibodies, and cell and gene therapies.

What you will do

• Lead CMC projects from proposal development through completion, coordinating with clients, technical teams, project management, and business development.
• Provide technical support during pre-sales activities, including client presentations, technical discussions, solution development, and proposal reviews.
• Act as the CMC technical lead and subject matter expert for biologics programs across cell line development, process development, GMP manufacturing, and related CMC activities.
• Lead client discussions on project scope, strategy, timelines, technical requirements, and deliverables.
• Serve as project leader for selected integrated CMC projects from U.S. clients.
• Represent ProBio's technical capabilities during client visits, conferences, and other business development activities.

Requirements

• Ph.D. in Biopharmaceutical Sciences or a related field with at least 3 years of relevant industry experience, or a Master's degree with at least 7 years of relevant industry experience.
• Strong experience in biologics CMC, including cell line development, process development, GMP manufacturing, and regulatory support.
• Experience supporting IND and/or BLA programs for antibody and protein biologics.
• Strong client-facing communication, presentation, leadership, problem-solving, and project management skills.
• Ability to collaborate across business development, project management, manufacturing, and technical functions.
• Excellent written and verbal English communication skills; the role must be performed remotely from the United States or European Union.

Culture & Benefits

• Remote work flexibility from eligible U.S. or EU locations.
• Medical, dental, and vision insurance.
• 401(k) retirement plan with company matching fully vested on the first day.
• Paid parental leave after three months, paid time off, sick time, holidays, and floating holidays.
• Flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, and well-being programs.