Drug Product Leader, Gene Therapy (Director) (Biotech)

TL;DR

Drug Product Leader, Gene Therapy (Director) (Biotech): Driving formulation and manufacturing process development from pre-clinical stages through commercial launch with an accent on drug product formulation, fill-finish processes, and GMP tech transfer. Focus on leading high-performing teams to advance the gene therapy pipeline and optimizing R&D effectiveness through strategic organizational leadership.

Location: Hybrid (Must be based in or be able to relocate to Philadelphia, PA or Holly Springs, NC); on-site presence > 50% required

Salary: $139,000 - $258,200

Company

hirify.global, a member of the Roche group and pioneer of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for serious and life-threatening diseases.

What you will do

• Direct the Gene Therapy Drug Product Development team from preclinical stages through commercial launch.
• Oversee drug product development activities including formulation, fill-finish processes, and in-use administration studies.
• Shape the gene therapy drug product development strategy and platform harmonization for Roche/hirify.global.
• Partner with manufacturing units to define process control strategies and support process validation.
• Support internal and external manufacturing tech transfer, including troubleshooting and investigations.
• Recruit, build, and mentor high-performing teams while fostering a culture of innovation and agility.

Requirements

• Ph.D., M.S., or B.S. degree in Biochemistry, Chemistry, Chemical Engineering, or Bioengineering.
• Extensive biopharmaceutical industry experience: 8+ years for Ph.D., 10+ years for Master's, or 12+ years for Bachelor's.
• Strong subject matter expertise in drug product formulation, Fill-Finish process development, and GMP tech transfer.
• Proven track record of people management and building high-performing teams.
• Strategic thinking and effective communication skills to partner with leadership and global stakeholders.
• Generally required to be on site > 50% of the time.

Nice to have

• Experience within a GMP Drug Product manufacturing environment.
• Specific experience in gene therapy, large biomolecules, or vaccines.

Culture & Benefits

• Relocation benefits are available for this position.
• Discretionary annual bonus based on individual and Company performance.
• Comprehensive corporate benefits package.
• Opportunity to work in a high-innovation environment dedicated to transformative gene therapies.