Director Manufacturing Science and Technology Operations (Biotech Manufacturing)

TL;DR

Director Manufacturing Science and Technology Operations (Biotech Manufacturing): Leading the CDMO drug-product technical operations team for oral solid dosage and sterile products with an accent on technology transfer and regulatory compliance. Focus on managing new product introductions, PPQ projects, and ensuring GMP standards across manufacturing and packaging functions.

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.