CMC Lead, SME (Biologics CMC)

Location: Remote from the United States or European Union

Company

hirify.global is a biotechnology company providing research and development services, while its ProBio subsidiary delivers end-to-end CDMO services for plasmids, antibodies, and cell and gene therapies.

What you will do

• Support business development during pre-sales activities, including client presentations, technical discussions, and solution development.
• Lead CMC technical activities for biologics programs across cell line development, process development, GMP manufacturing, and related services.
• Coordinate with CMC functional teams and Project Management to deliver projects on schedule and in line with client expectations.
• Lead client discussions on project scope, strategy, timelines, technical requirements, and deliverables.
• Review proposals, project plans, and client-facing technical documentation.
• Represent ProBio at client visits, conferences, and trade shows, and lead selected integrated CMC projects for U.S. clients.

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 other technical functions.
• Excellent written and verbal English communication skills.

Culture & Benefits

• Remote work flexibility from the United States or European Union.
• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match fully vested on the first day.
• Paid parental leave after three months, paid time off, vacation, sick time, floating holidays, and company holidays.
• Flexible spending and health savings accounts, life and disability insurance, commuter benefits, and well-being programs.
• Peer-to-peer recognition programs and an inclusive equal-opportunity workplace.