Senior Director, QC Strategy for Biologics & ADC

Crescent Biopharma; Waltham (MA); On-site; USD 260,000 - 285,000; Full time

Benefits offered by this job

Equity

Performance bonus

Employer-paid benefits

Flexible PTO

Professional development

Job summary

Crescent Biopharma is seeking a Senior Director, Quality Control to lead QC strategy across early development through commercialization, coordinating with Analytical Sciences, GMP QA, CMC, Regulatory Affairs, and external partners. The role focuses on ensuring reliable release and stability testing while building the QC network.

This hands-on leader will drive method transfer, validation, and lifecycle management, balancing scientific rigor with regulatory compliance to support Phase 3, PPQ,

Qualifications

• Bachelor's degree in life sciences or related discipline
• 10-12 years of progressive experience in biologics QC or related CMC functions, including leadership of GMP QC operations in an outsourced environment
• Experience with biologics analytical methods; ADC and bispecific modalities are a plus
• Experience supporting biologics from clinical development through Phase 3, PPQ, BLA/MAA, and commercial readiness
• Proven ability to transition methods from development into routine GMP QC use and manage lifecycle of analytical methods

Responsibilities

• Define and implement Crescent's phase-appropriate QC strategy and operating model across early development, Phase 3, PPQ, regulatory submission, and commercialization
• Oversee QC activities for drug substance, drug product, intermediates, finished goods, in-process, release, characterization, and stability testing across the portfolio
• Provide QC oversight during early development while Analytical Sciences leads method development and PPQ readiness
• Lead outsourced GMP QC operations and ensure timely, compliant release and stability testing for clinical and future commercial supply
• Partner with Analytical Sciences, CMC, Regulatory Affairs, and QA on specifications, stability strategy, and data review
• Establish reference standards and critical reagent programs with lifecycle planning
• Provide technical leadership for investigations, deviations, CAPAs, and change control
• Lead alliance management with CDMO QC functions and external partners
• Support QC input to CMC/regulatory strategies and IND/IMPD, BLA/MAA activities
• Mentor staff and foster a culture of scientific rigor and continuous improvement

Skills

Collaborative leadership

GMP knowledge

Cross-functional collaboration

Regulatory submissions

Quality systems

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Crescent Biopharma is seeking a Senior Director, Quality Control to lead QC strategy across early development through commercialization, coordinating with Analytical Sciences, GMP QA, CMC, Regulatory Affairs, and external partners. The role focuses on ensuring reliable release and stability testing while building the QC network.

This hands-on leader will drive method transfer, validation, and lifecycle management, balancing scientific rigor with regulatory compliance to support Phase 3, PPQ,