CMC Process Development Lead (m/f/d)

TL;DR

CMC Process Development Lead: Lead the development and validation of manufacturing processes for starting materials, drug products, and reagent kits with an accent on scale-up, analytical method development, and fill-and-finish activities. Focus on managing CDMOs, ensuring GMP compliance, and preparing CMC documentation for regulatory submissions.

Location: Remote EU

Company

hirify.global innovates quantum technology using organic molecules for metabolic imaging and quantum computing applications in drug discovery and cancer treatment, headquartered in Ulm, Germany.

What you will do

• Manage development, optimisation, and scale-up of manufacturing processes for starting materials and drug products.
• Collaborate with CDMOs on process development, technology transfer, and validation to meet quality and regulatory standards.
• Develop and validate analytical methods for process monitoring, release testing, and stability studies.
• Define sterilisation strategies and drive fill-and-finish process development for clinical manufacturing.
• Support technical set-up of clinical manufacturing and testing sites.
• Prepare and review CMC documentation, protocols, reports, and regulatory submission content per GMP and ICH guidelines.

Requirements

• MSc or PhD in pharmaceutical sciences, chemical engineering, or related field.
• At least 3 years experience in process development, manufacturing, or related role in pharma/biotech.
• Expertise in CMC development, technology transfer, and manufacturing process validation.
• Experience managing CDMO partnerships and external manufacturing partners.
• Strong understanding of GMP, GLP, ICH guidelines, and regulatory requirements.
• Excellent problem-solving, collaboration, and technical writing skills.

Nice to have

• Experience in contrast agents, radiopharmaceuticals, or drug-device combinations.

Culture & Benefits

• Remote or hybrid working model.
• Indefinite employment contract and 30 vacation days.
• Flexible working hours, annual health budget (Allianz bKV), and EGYM Wellpass.
• International team from over 30 nationalities with open communication and collaboration.
• Relocation support.
• Competitive base salary and stock options.