Cell Therapy CMC & Manufacturing Leader

QLD Biotherapeutics Inc; Boston (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

A biotherapeutics company based in Boston is seeking a Director/Associate Director to lead CMC strategy and manufacturing for cell therapy development programs. The ideal candidate has over 8 years of biotech experience, with a proven track record in advancing programs to clinical trials. This role offers an opportunity to significantly impact the transition from preclinical to clinical development in a collaborative environment.

Qualifications

• 8+ years of biotech/pharma experience required.
• 5+ years in cell therapy CMC leadership necessary.
• Hands-on experience with iPSC/MSC biology is essential.

Responsibilities

• Lead development and implementation of CMC strategy.
• Optimize processes for iPSC- or MSC-derived products.
• Contribute to regulatory filings for IND/CTA.

Skills

Leadership

Project management

Cross-functional communication

GMP compliance

Education

PhD in Cell Biology, Immunology, or related field

Job description

A biotherapeutics company based in Boston is seeking a Director/Associate Director to lead CMC strategy and manufacturing for cell therapy development programs. The ideal candidate has over 8 years of biotech experience, with a proven track record in advancing programs to clinical trials. This role offers an opportunity to significantly impact the transition from preclinical to clinical development in a collaborative environment.