Director Manufacturing Science and Technology Operations (Biotech Manufacturing)

Location: On-site in Middletown, DE

Company

hirify.global is a global pharmaceutical and biotech CDMO providing a broad portfolio of R&D and manufacturing services.

What you will do

• Manage the introduction of new products and co-line evaluation, coordinating with R&D and other key departments.
• Oversee technology transfer processes for both clinical and PPQ projects from R&D to production.
• Direct cleaning verification and validation processes, including protocol drafting and annual reviews.
• Provide technical support for commercial production, including deviation investigations and process improvements.
• Lead customer and official regulatory audits, ensuring compliance with FDA, EMA, and ICH standards.
• Monitor regulatory guidelines and implement necessary updates to internal operational processes.

Requirements

• BS/MS in Pharmacy or chemistry-related major.
• 10+ years of relevant work experience in pharmaceutical production technology.
• Strong knowledge of FDA, EMA, and ISO regulatory requirements.
• Proficiency in lean production management methods and basic statistics.
• English: Proficiency in oral and written communication required.
• Ability to travel up to 20% (domestic and international).

Culture & Benefits

• Commitment to being an Equal Opportunity Employer.
• Opportunity to provide scientific leadership in a high-impact CDMO environment.
• Professional growth in a global organization specializing in biotech manufacturing.